Volume 56 (2018), No. 11/2018(November)
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Review
Adverse effects of chronic nicotine exposure on the kidney: Potential human health implications of experimental findings
Istvan Arany, Mary Taylor, Tibor Fülöp, and Mehul Dixit
Price
42.00 $
Page No. 501
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (501-506)
Adverse effects of chronic nicotine exposure on the kidney: Potential human health implications of experimental findings
Istvan Arany1, Mary Taylor2, Tibor Fülöp3#4, and Mehul Dixit1
1Division of Pediatric Nephrology, 2Division of Critical Care, Department of Pediatrics, University of Mississippi Medical Center, Jackson, MS, 3Division of Nephrology, Department of Medicine, Medical University of South Carolina, and 4Medical Services, Ralph H. Johnson VA Medical Center, Charleston, SC, USA
With the increasing popularity of E-cigarettes, chronic exposure to nicotine (NIC) is emerging as a novel risk factor for the kidney. NIC increases oxidative stress in the kidneys, which impairs the viability and function of renal tubular and endothelial cells, alters renal hemodynamics, and compromises overall kidney function. Moreover, long-term NIC exposure increases the risk of development and progression of chronic kidney diseases and may escalate the impact of coexisting morbidities such as obesity-associated renal disease, hypertension, renal transplant status, or the toxicity of various anticancer agents. In this review, we summarize experimental findings describing increased renal risk of chronic NIC exposure and explore therapeutic interventions to alleviate adverse effects of NIC.
Correspondence to:
Istvan Arany, PhD
Department of
Pediatrics, Pediatric Nephrology
Research Wing Room R116B,
2500 N. State Street, Jackson, MS 39216, USA
Email: [email protected]
Original
Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men
Shingo Tanaka, Sayaka Harada, Naoto Hiramatsu, Ryou Nakaya, and Masaki Kawamura
Price
42.00 $
Page No. 507
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (507-517)
Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men
Shingo Tanaka1, Sayaka Harada1, Naoto Hiramatsu1, Ryou Nakaya1, and Masaki Kawamura2
1Takeda Pharmaceutical Company Ltd., Osaka, and 2Takeda Pharmaceutical Company Ltd., Tokyo, Japan
Objective: Namilumab is an investigational human monoclonal antibody to human granulocyte-macrophage colony-stimulating factor (GM-CSF). A phase I study of repeated namilumab dosing (150 or 300 mg subcutaneously) in non-Japanese patients with rheumatoid arthritis reported no safety concerns. The objective of this study was to report the safety (primary endpoint) and pharmacokinetic/pharmacodynamic effects of namilumab in healthy Japanese and Caucasian men aged 20 – 45 years (NCT02354599). Materials and methods: 24 Japanese subjects were randomized to a single dose of namilumab (80, 150, or 300 mg; n = 6/group) or placebo (n = 6; 2 subjects randomized/matched dose); 8 Caucasian subjects received namilumab 150 mg (n = 6) or placebo (n = 2). Results: Overall, 29 subjects completed the study (2 withdrew voluntarily; 1 due to a serious adverse event (AE) unrelated to treatment). Baseline demographics were similar across treatment groups; mean age and weight were higher in Caucasians. Namilumab was well tolerated, with no notable safety concerns or pharmacokinetic/pharmacodynamic differences between Japanese and Caucasian subjects. AEs were mild to moderate, with no dose-proportional increase in Japanese subjects. Area under the serum concentration-time curve from zero to infinity (AUC<sub>0–∞</sub>) and maximum serum concentration (C<sub>max</sub>) increased in a dose-proportional manner in Japanese subjects. AUC<sub>0–∞</sub> was similar in Japanese (575.2 µg×day/mL) and Caucasian (559.7 µg×day/mL) 150-mg groups. C<sub>max</sub> was ~ 40% higher in Japanese subjects. Mean plasma total GM-CSF concentration-time profiles were similar in the Japanese and Caucasian 150-mg groups. Namilumab induced no clinically-relevant antibody response. Conclusion: Namilumab was well tolerated in Japanese and Caucasian subjects; namilumab 150 mg had similar pharmacokinetics in both populations, supporting further clinical development of this dose.
Correspondence to:
Shingo Tanaka, MSc
Takeda Pharmaceutical Company Ltd
1-1 Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645 Japan
Email: [email protected]
Original
Development of clinical pharmacy services in Australia, Austria, Belgium, Bosnia-Herzegovina, Canada, Germany, Japan, Kosovo, Switzerland, the Netherlands, Thailand, USA and correlation with educational standards, level of research, and implemen
Olaf Rose, Hartmut Derendorf, Susanne Erzkamp, Kenji Fujita, Alexander Hartl, Kreshnik Hoti, Ines Krass, Emina Obarcanin, Jan Saevels, Pornchanok Srimongkon, Martina Teichert, and Ross T. Tsuyuki
Price
42.00 $
Page No. 518
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (518-530)
Development of clinical pharmacy services in Australia, Austria, Belgium, Bosnia-Herzegovina, Canada, Germany, Japan, Kosovo, Switzerland, the Netherlands, Thailand, USA and correlation with educational standards, level of research, and implemen
Olaf Rose1#3, Hartmut Derendorf2, Susanne Erzkamp3, Kenji Fujita4, Alexander Hartl5, Kreshnik Hoti6, Ines Krass4, Emina Obarcanin7, Jan Saevels8, Pornchanok Srimongkon9, Martina Teichert10, and Ross T. Tsuyuki11
1Department of Pharmacotherapy & Translational Research, 2Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, FL, USA, 3Elefanten-Apotheke, Steinfurt, Germany, 4University of Sydney, Faculty of Pharmacy, NSW, Australia, 5Rotunden Apotheke, Vienna, Austria, 6University of Prishtina, Division of Pharmacy, Prishtina, Kosovo, 7Heinrich Heine University, Department of Clinical Pharmacy and Therapeutics, Düsseldorf, Germany, 8Association of Pharmacists Belgium, Brussels, Belgium, 9Mahasarakham University, Faculty of Pharmacy, Mahasarakham, Thailand, 10Royal Dutch Association for the Advancement of Pharmacy, KNMP, The Hague, The Netherlands, and 11EPICORE Centre, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada
Objective: This study aimed to compare determinants of professional development between different countries to identify barriers and facilitators of development towards clinical pharmacy services and stimulate discussion of under-used potential and opportunities. Materials: The study was conceived as a survey. The questionnaire was administered to a group of experts. Methods: The survey was conducted as a cross-sectional study with descriptive and correlation analysis. A questionnaire was developed and adjusted to the study focus, covering aspects on general regulations for community pharmacies, professional education, implementation of clinical pharmacy services, and research in patient care. Results were compared for analyses. Results: A total of twelve countries were included in this survey. Pharmacy studies took between 4 and 6 years plus residency in most countries. Curricula remained drug-oriented only in Austria, Bosnia-Herzegovina, and Germany; these three countries had the least pharmacotherapy content in their curricula. Canada, the USA, and Australia have established clinical pharmacy services in almost all fields of practice. Most other countries have implemented at least some clinical services, with the exception of Bosnia-Herzegovina, Germany, and Kosovo. The correlation coefficient between education, research, and implementation was 0.91. Conclusion: The results of the survey show that clinical pharmacy services are established to very different extents among the participating countries. The strong correlation suggests that achieving a successful transition in professional practice needs to address several aspects of education and research to reach progress. The collected data might help to identify potential areas of improvement to foster implementation of clinical pharmacy services.
Correspondence to:
Olaf Rose, PharmD, PhD
University of Florida, College of Pharmacy
Department of Pharmacotherapy and Translational Research
1225 Center Drive, HPNP Bldg. Room 334
Gainesville, FL 32610-0486, USA
Email: [email protected]
Original
Efficacy and safety of a fixed-dose combination of D-norpseudoephedrine, triiodothyronine, atropine, aloin, and diazepam in obese patients
Cecilia Fernández del Valle-Laisequilla, Cristian Trejo-Jasso, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Rodríguez-Silverio, Héctor Isaac Rocha-González, and Juan Gerardo Reyes-García
Price
42.00 $
Page No. 531
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (531-538)
Efficacy and safety of a fixed-dose combination of D-norpseudoephedrine, triiodothyronine, atropine, aloin, and diazepam in obese patients
Cecilia Fernández del Valle-Laisequilla1, Cristian Trejo-Jasso2, Juan Carlos Huerta-Cruz2, Lina Marcela Barranco-Garduño3, Juan Rodríguez-Silverio2, Héctor Isaac Rocha-González2, and Juan Gerardo Reyes-García2
1Laboratorios Medix S.A. de C.V., 2Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, and 3Unidad de Investigación en Farmacología, Instituto Nacional de Enfermedades Respiratorias, Ismael Cosio Villegas, Secretaría de Salud, Mexico City, Mexico
Objective: A fixed-dose combination (FDC) of D-norpseudoephedrine, triiodothyronine, atropine, aloin, and diazepam is used in Mexico for the short-term treatment of obesity; however, its efficacy and safety have been scarcely studied. The aim of this study was to analyze the efficacy and safety of this FDC in Mexican adult overweight and obese patients by a prospective, uncontrolled, multicenter, phase IV open-label study. Materials and methods: 3,290 patients with a body mass index (BMI) ˃ 27 kg/m2 were included in the current study. Primary outcome was the absolute body weight loss, whilst secondary outcomes were the improvement of anthropometric and cardiometabolic parameters as well as the description of adverse events. Results: The FDC decreased the body weight and BMI by –9.0 ± 5.6 kg and –3.4 ± 2.2 kg/m2, respectively, at 6 months. In addition, 43.3% and 14.3% of subjects achieved at least 5% or 10% weight loss at 6 months, respectively. The FDC also significantly improved waist circumference, hip circumference, body fat, visceral fat, systolic blood pressure, diastolic blood pressure, diabetes risk, and mortality risk, at 3 and 6 months. Moreover, the FDC seems to have better results in the following order: obese grade 3 ≈ obese grade 2 ˃ obese grade 1 ˃ overweight patients. Mild mouth dryness, anxiety, and headache were the main reported adverse events. Conclusion: Data suggest that the FDC is effective and well tolerated for the short-term therapy of overweight and obesity in Mexican patients.
Corrigendum can be found on here.Correspondence to:
Gerardo Reyes-García, MD, PhD
Sección de Estudios de Posgrado e Investigación
Escuela Superior de Medicina, Instituto Politécnico Nacional
Plan de San Luis y Díaz Mirón s/n
Col. Casco de Santo Tomas
Del. Miguel Hidalgo, 11340 México, D.F. Mexico
Email: [email protected]
Original
Effect of nasally exhaling budesonide/formoterol dry powder inhaled at “fast” inspiratory flow on eosinophilic chronic rhinosinusitis
Satoshi Hamada, Daiki Hira, Yoshiki Kobayashi, and Hirotaka Yasuba
Price
42.00 $
Page No. 539
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (539-543)
Effect of nasally exhaling budesonide/formoterol dry powder inhaled at “fast” inspiratory flow on eosinophilic chronic rhinosinusitis
Satoshi Hamada1#2, Daiki Hira3#4, Yoshiki Kobayashi5, and Hirotaka Yasuba2
1Department of Respiratory Medicine, Hikone Municipal Hospital, Hikone, Shiga, 2Department of Airway Medicine, Mitsubishi Kyoto Hospital, Kyoto, 3College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, 4Department of Pharmacy, Shiga University of Medical Science Hospital, Otsu, Shiga, and 5Department of Otolaryngology, Kansai Medical University, Hirakata, Osaka, Japan
Background: Budesonide (BUD)/formoterol (FM) dry powder inhaler has a feature that the fine particle fraction output is dependent on users’ inspiratory flow rate. The aim of this study was to assess the amount of nasally exhaled BUD/FM inhaled in the different inspiratory flow rate. We also examined the effect of nasal exhalation of BUD/FM dry powder inhaled on radiographic evidence of sinonasal inflammation in asthmatic patients with eosinophilic chronic rhinosinusitis (ECRS). Materials and methods: The quantitative amount of nasally exhaled BUD/FM was analyzed by high-performance liquid chromatography in 3 healthy subjects. We retrospectively evaluated the effect of nasal exhalation of BUD/FM dry powder inhaled at > 60 L/min on radiographic evidence of sinonasal inflammation, which was assessed according to the Lund-Mackay staging (LMS) system, in 7 consecutive patients with asthma and ECRS. Results: The amount of nasally exhaled BUD in the setting of inhaling BUD/FM dry powder inhaler at 60 L/min (subject 1: 25.8 ng/mL; subject 2: 37.3 ng/mL; subject 3: 30.0 ng/mL) was high compared to at 30 L/min (subject 1: 9.3 ng/mL; subject 2: 4.1 ng/mL; subject 3: 9.2 ng/mL) in each healthy subject. Nasal exhalation of BUD/FM dry powder significantly reduced total (p = 0.018) and ethmoid LMS scores (p = 0.0077). Conclusion: Nasal exhalation technique of BUD/FM dry powder inhaled at “fast” inspiratory flow has a potential of simultaneously treating asthma and ECRS.
Correspondence to:
Satoshi Hamada, MD, PhD
Department of Respiratory Medicine
Hikone Municipal Hospital
1882 Hassakacho, Hikone, 522-8539, Japan
Email: sh1124@
kuhp.kyoto-u.ac.jp
Original
Pharmacodynamic effects of voglibose administered alone, administered with metformin, and administered with metformin in a fixed-dose combination in healthy Korean subjects
Ho-Sook Kim, Minkyung Oh, Eun Ji Kim, Geun Seog Song, Eun-young Kim, and Jae-Gook Shin
Price
42.00 $
Page No. 544
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (544-550)
Pharmacodynamic effects of voglibose administered alone, administered with metformin, and administered with metformin in a fixed-dose combination in healthy Korean subjects
Ho-Sook Kim1#2, Minkyung Oh1, Eun Ji Kim3, Geun Seog Song4, Eun-young Kim1#2, and Jae-Gook Shin1#2
1Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine, 2Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, and 3Clinical Research Team, CJ HealthCare, Seoul, 4Clinical Development Department, CJ HealthCare, Seoul, Republic of Korea
Objective: This study aimed at exploring the effects of metformin on the pharmacodynamics of voglibose, while investigating the pharmacodynamics between a fixed-dose combination (FDC) of voglibose/metformin and coadministered doses of voglibose and metformin tablets in healthy Korean subjects. Materials and methods: A randomized, open-label, 2×3×3 crossover study with a 9-day washout period was conducted in 30 healthy subjects. All subjects received orally administered voglibose alone, individual voglibose and metformin tablets, or FDC 3 times daily for 5 days. Oral sucrose was administered on day –1 (pretreatment) and at 10 minutes after the morning dose of the study drug on day 5 of each period. Plasma glucose and serum insulin were measured over the course of 2 hours following sucrose loading. Results: 21 subjects completed the study. The geometric mean ratios (GMR) of ΔC<sub>max</sub> and the AUC of glucose for voglibose plus metformin vs. voglibose alone were 0.995 (90% CI, 0.800 – 1.237) and 0.969 (90% CI, 0.949 – 0.990), respectively; the GMRs for individual tablets vs. FDC were 1.118 (90% CI, 0.930 – 1.344) and 1.010 (90% CI, 0.974 – 1.048), respectively. A relatively smaller number of subjects experienced adverse events when receiving voglibose alone compared to those administered FDC or metformin and voglibose. There were no significant differences in adverse events between individual voglibose and metformin tablets and FDC. Conclusion: Coadministered metformin did not have statistically or clinically significant effects on the pharmacodynamics of voglibose in healthy subjects. Glucose levels following sucrose loading seem not to be clinically different between FDC and individual tablets of voglibose and metformin.
Correspondence to:
Jae-Gook Shin, MD, PhD
Department of Pharmacology and Clinical Pharmacology
Inje University College of Medicine and Busan Paik Hospital
633-165 Gaegum-dong, Jin-gu, Busan 614-735, Korea
Email:
[email protected]
Original
NSAIDs may prevent EGFR-TKI-related skin rash in non-small cell lung cancer patients
Yohei Iimura, Hitoshi Shimomura, Takeo Yasu, Keiko Imanaka, Ryuichi Ogawa, Akihiko Ito, Kenichi Suzuki, Gaku Yamaguchi, Norihisa Kawasaki, and Chimori Konaka
Price
42.00 $
Page No. 551
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (551-554)
NSAIDs may prevent EGFR-TKI-related skin rash in non-small cell lung cancer patients
Yohei Iimura1, Hitoshi Shimomura1, Takeo Yasu2, Keiko Imanaka1, Ryuichi Ogawa3, Akihiko Ito4, Kenichi Suzuki5, Gaku Yamaguchi6, Norihisa Kawasaki6, and Chimori Konaka6
1Department of Pharmacy, International University of Health and Welfare Ichikawa Hospital, Chiba, 2Department of Pharmacy, The Institute of Medical Science, The University of Tokyo, 3Department of Pharmacotherapy, Meiji Pharmaceutical University, 4Department of Medicinal Therapy Research, Meiji Pharmaceutical University, 5Department of Pharmacotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, and 6Department of Respiratory Surgery, International University of Health and Welfare Ichikawa Hospital, Chiba, Japan
Objectives: Skin rash is a common adverse event induced by epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). Here, we aimed to predict factors that reduce EGFR-TKI-related skin rash. Materials and methods: We conducted a single-center, retrospective study to predict factors that reduce skin rash in patients undergoing treatment for non-small cell lung cancer (NSCLC) with EGFR-TKIs using Cox proportional hazards model. Results: Cox proportional hazard analysis revealed that coadministration of non-steroidal anti-inflammatory drug (NSAID) had protective effects against rash. Steroid coadministration showed a trend to being effective in reducing rash. Conclusion: NSAIDs may be useful in preventing EGFR-TKI-related skin rash.
Correspondence to:
Yohei Iimura, BSc
Department of Pharmacy
International University of Health and
Welfare Ichikawa Hospital
6-1-14 Kounodai, Ichikawa-shi, Chiba 272-0827, Japan
Email: [email protected]
Bioavailability Section
Bioequivalence study of the antiepileptic drug levetiracetam in concentrated solution for injection versus oral tablets in healthy Chinese subjects under fasting conditions: A randomized, open-label, three-way crossover study
Junyu Xu, Xia Zhao, Zining Wang, Ying Zhou, Xiaoqin Yang, and Yimin Cui
Price
42.00 $
Page No. 555
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (555-561)
Bioequivalence study of the antiepileptic drug levetiracetam in concentrated solution for injection versus oral tablets in healthy Chinese subjects under fasting conditions: A randomized, open-label, three-way crossover study
Junyu Xu1, Xia Zhao1, Zining Wang1, Ying Zhou1, Xiaoqin Yang2, and Yimin Cui1
1Department of Pharmacy, Peking University First Hospital, Beijing, and 2Sichuan Dingnuo Taichen Technology Co., Ltd., Chengdu, Sichuan, China
Objective: The objective of this study was to evaluate the bioequivalence between single-dose intravenous (IV) infusion injection (the infusion time was 15 minutes and 45 minutes) and tablets of 1,000 mg levetiracetam in healthy Chinese male subjects. Materials and methods: This was a randomized, open-label, three-way crossover bioequivalence study. All of the 24 healthy male subjects received a treatment of 45-minute IV infusion, 15-minute IV infusion, and oral tablets. Results: After a single dose, the AUC, V<sub>d</sub>, Cl, and T<sub>1/2</sub> were all essentially consistent among the treatment; t<sub>max</sub> of 15-minute IV, 45-minute IV, and oral tablets were 0.25 hours, 0.75 hours, and 0.5 hours, respectively. The C<sub>max</sub> of the 15-minute IV was higher than the value of the 45-minute IV and the oral tablets. The geometric mean of the 15-minute IV/oral and the 45-minute IV/oral ratios were 101.02% (90% CI, 98.95 – 103.12) and 98.22% (90% CI, 96.22 – 100.27), respectively, for AUC<sub>0–t</sub>. And those for C<sub>max</sub> were 169.09% (90% CI, 155.21 – 184.21) and 106.95 (90% CI, 98.20 – 116.48), respectively. There were no severe adverse events or other adverse events with clinical significance during the study. Conclusion: In these healthy subjects, the results showed that 45-minute IV and oral tablets were bioequivalent. The t<sub>max</sub> of the 15-minute IV and oral tablets were significantly different. The t<sub>max</sub> of the oral tablets was between that of the 15-minute IV and the 45-minute IV. The elimination of injection and oral tablets in humans was similar. Levetiracetam concentrated solution for injection and oral tablets were safe for healthy Chinese male subjects in this study.
Correspondence to:
Prof. Yimin Cui
Department of Pharmacy
Peking University First Hospital
No.6, Da Hong Luo Chang Street, Xicheng District
Beijing, 100034, China
Email:
[email protected]
Bioavailability Section
Evaluation of reference-scaled average bioequivalence of two oral formulations of abiraterone acetate in healthy Chinese subjects
Cuiyun Li, Yanhua Ding, Deming Yang, Meng Wang, Yue Hu, Hong Zhang, Xiaoxue Zhu, Guiling Chen, Xiaojiiao Li, Min Wu, Jingrui Liu, Hong Chen, Chengjiao Liu, Zhenwei Shen, and Bin Liu
Price
42.00 $
Page No. 562
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 11/2018 (562-570)
Evaluation of reference-scaled average bioequivalence of two oral formulations of abiraterone acetate in healthy Chinese subjects
Cuiyun Li1, Yanhua Ding1, Deming Yang1, Meng Wang1, Yue Hu1, Hong Zhang1, Xiaoxue Zhu1, Guiling Chen1, Xiaojiiao Li1, Min Wu1, Jingrui Liu1, Hong Chen1, Chengjiao Liu1, Zhenwei Shen2, and Bin Liu3
1Phase I Clinical Unit, China-Frontage USA, First Hospital, 2First Hospital and Institute of Immunology, and 3Department of Hand Surgery, First Hospital, Jilin University, Changchun, Jilin, China
Objective: This study was designed to evaluate the pharmacokinetic (PK) properties and bioequivalence (BE) of two 250-mg tablet formulations of abiraterone acetate: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult Chinese subjects under fasted (n = 40) and fed (n = 40) conditions. Materials and methods: The comparison was performed using a single-dose, open, randomized, and four-way replicate study. The concentration of abiraterone in blood samples taken over 48 hours was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS). To assess the BE of the test and reference formulations, confidence intervals (CI, 90%) for the peak plasma concentration (C<sub>max</sub>) and area under the concentration-time curves (AUC<sub>0–t</sub> and AUC<sub>0–∞</sub>) were calculated using the reference-scaled average bioequivalence (RSABE) method. Results: The results showed that the 90% CIs for the ratios of C<sub>max</sub>, AUC<sub>0–t</sub>, and AUC<sub>0–∞</sub> in the fasted study were 90.14 – 114.11, 93.96 – 115.07, and 93.72 – 113.331, respectively. For the fed study, the 90% CIs were 81.83 – 102.51, 91.51 – 104.89, and 91.46 – 104.58, respectively. Conclusion: In conclusion, the tested 250-mg abiraterone tablets were bioequivalent to 250-mg Zytiga tablets (reference) under both fasted and fed conditions. In addition, food intake increased the systemic exposure and C<sub>max</sub> of abiraterone by 3-fold and 7-fold, respectively.
Correspondence to:
Prof. Bin Liu, MD
Department of Hand Surgery
First Hospital, Jilin University, Changchun, Jilin, 130021, China
Email: [email protected]
