Original
Pharmacokinetics and safety profile of desmopressin oral tablet formulations in healthy Chinese subjects under fasting and fed conditions
Xiaojiao Li, Hong Zhang, Xiaoxue Zhu, Cuiyun Li, Hong Chen, Jingrui Liu, Guiling Chen, Min Wu, Chengjiao Liu, Zhenwei Shen, Junqi Niu, Bin Liu, and Yanhua Ding
Price
42.00 $
Volume 56 (2018) p. 434 - 442
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 9/2018 (434-442)
Pharmacokinetics and safety profile of desmopressin oral tablet formulations in healthy Chinese subjects under fasting and fed conditions
Xiaojiao Li1, Hong Zhang1, Xiaoxue Zhu1, Cuiyun Li1, Hong Chen1, Jingrui Liu1, Guiling Chen1, Min Wu1, Chengjiao Liu1, Zhenwei Shen1, Junqi Niu2, Bin Liu3, and Yanhua Ding1
1Phase I Clinical Trial Unit, 2Department of Hepatology, and
3Hand Surgery Department, First Hospital, Jilin University, Jilin, China
Objective: Desmopressin acetate (DDAVP®) is a synthetic analogue of the pituitary hormone vasopressin. Until now, few studies of desmopressin have focused on the pharmacokinetics (PK) or food effects in Asian populations. This study aimed to assess the effect of food intake on the PK of desmopressin and bioequivalence of two tablet formulations in Chinese subjects. Materials and methods: A single-center, single-dose, randomized, open-label, two-period crossover study was conducted in 104 healthy Chinese volunteers under fasted or fed conditions (52 volunteers for each condition). Blood samples were collected up to 14 hours after administration of oral desmopressin tablets (0.6 mg; 0.2 mg × 3) in each period. Plasma desmopressin concentrations were analyzed by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). PK and bioavailability parameters were calculated. Adverse events (AEs) were also recorded. Results: No significant differences in mean (standard deviation, SD) PK parameters were observed between formulation 1 (F1) and formulation 2 (DDAVP®; F2) under both fasted and fed conditions. All AEs observed were mild and resolved quickly without treatment. The maximum concentration (C<sub>max</sub>) and area under the curve (AUC) were significantly decreased (p < 0.01) when the drug was taken with food, compared with fasted subjects. Conclusion: These findings suggest that both tablet formulations were well tolerated. Food can significantly decrease the exposure of desmopressin.
Correspondence to:
Bin Liu
Hand Surgery Department, First Hospital,
Jilin University
No. 71 Xinmin Street,
Changchun 130021, 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 $
Volume 56 (2018) p. 562 - 570
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]
Bioavailability Section
A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects
Hong Zhang, Xiaoxue Zhu, Haijing Wei, Cuiyun Li, Hong Chen, Xiaojiao Li, Min Wu, Jingrui Liu, Guiling Chen, Hui Zhou, Shirui Zheng, and Yanhua Ding
Price
42.00 $
Volume 57 (2019) p. 167 - 174
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 3/2019 (167-174)
A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects
Hong Zhang1, Xiaoxue Zhu1, Haijing Wei1, Cuiyun Li1, Hong Chen1, Xiaojiao Li1, Min Wu1, Jingrui Liu1, Guiling Chen1, Hui Zhou2, Shirui Zheng2, and Yanhua Ding1
1The First Hospital of Jilin University, Changchun, Jilin, and 2Innovent Biologics (Suzhou), Suzhou, China
Objective: To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of the proposed biosimilar IBI305 with those of bevacizumab in healthy male subjects. Design: A phase I, randomized, double-blinded, two-arm, parallel-group study. Settings: The study was conducted in The First Hospital of Jilin University, Changchun, China, from March 2017 to November 2017. Participants: A total of 100 healthy male subjects were enrolled, with 48 in the IBI305 group and 50 in bevacizumab group included in the final analysis. Intervention: In a 16-week study course, participants were randomized at a 1:1 ratio to receive intravenous administration of either a single dose of 3 mg/kg IBI305 (n = 50) or bevacizumab (n = 50). Outcome measures: The primary endpoints were area under the concentration-time curve from zero to the time of the last measurable concentration (AUC0–t) and AUC curve from zero to infinity (AUC0–∞). The secondary endpoints include the other PK parameters, immunogenicity, and safety measurements. Results: AUC0–t, AUC0–∞, maximum concentration observed (Cmax), half-life (T1/2), drug clearance, and volume of distribution were similar between IBI305- and bevacizumab-treated subjects. For AUC0–∞, AUC0–t, and Cmax, the 90% confidence intervals for the ratios of geometric means were fully within the range 0.80 – 1.25, confirming the bioequivalence of the two investigational agents. Furthermore, no apparent difference in adverse events was found between the two groups. Conclusion: This study demonstrated the similarity of PK, immunogenicity, and safety profiles of IBI305 to those of bevacizumab.Correspondence to:
Yanhua Ding, MD
Phase I Clinical Trials Unit
The First Hospital of Jilin University
No.71 Xinmin Street, Changchun,Jilin, China
Email: dingyanhua2003@
126.com
Viewpoint
Network target theory and network pharmacology: Next generation drug research in medicine using AI models
Xiaojing Han, Chenghui Wang, Rui Li, Qiuye Wang, Wenbo Lu, and Weidong Pan
Price
42.00 $
Volume 62 (2024) p. 151 - 154
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 4/2024 (151-154)
Network target theory and network pharmacology: Next generation drug research in medicine using AI models
Xiaojing Han1', Chenghui Wang2', Rui Li1, Qiuye Wang1, Wenbo Lu1, and Weidong Pan1,2
1First Department of Encephalopathy, Anhui Provincial Hospital of Integrated Chinese and Western Medicine (The Third Affiliated Hospital of Anhui University of Chinese Medicine), Anhui, and 2Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
*These authors contributed equally to this work as co-first authors.Correspondence to:
Professor Weidong Pan
Department of Neurology
Shuguang Hospital Affiliated to Shanghai University
of Traditional Chinese Medicine
Shanghai, China
Email: [email protected]
Original
Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part 3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis
Rui Li, Xiaojing Han, Qiudong Wang, Chenghui Wang, Wei Jing, Haihan Zhang, Jun Wang, and Weidong Pan
Price
42.00 $
Volume 62 (2024) p. 169 - 177
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 4/2024 (169-177)
Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part 3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis
Rui Li1#2, Xiaojing Han2, Qiudong Wang3, Chenghui Wang1, Wei Jing1, Haihan Zhang1, Jun Wang1, and Weidong Pan1#2#4
1Deparment of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 2First Department of Encephalopathy, Anhui Provincial Hospital of Integrated Chinese and Western Medicine (The Third Affiliated Hospital of Anhui University of Chinese Medicine), Anhui, 3Department of Integrative Neurology, Pudong Traditional Chinese Medicine Hospital, and 4Encephalopathy Laboratory, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
Objective: The aim of this clinical study is to obtain evidence for the clinical efficacy of Bu-Shen-Jian-Pi formula (BSJP), a traditional Chinese medicine, used for the treatment of amyotrophic lateral sclerosis, a relatively rare, progressive and usually fatal disease possibly associated with alterations in tissue redox status, hypoxia, and muscular injury.
Background: The active agents in BSJP formula† causing apoptosis, modulation of redox changes, and alterations in the immune status have been studied previously by us using cell cultures. The findings from these investigations have been incorporated into pharmacology databases employed in our analysis of BSJP using network pharmacology analysis/artifical intelligence. This information has been used here in the design of the investigation and to optimize evaluation of the clinical efficacy and usefulness of this herbal medicine, as far as possible using evidence-based medicine criteria.
Materials and methods: The design of the study was a randomized multi-center, controlled clinical trial in 127 patients with confirmed diagnoses of amyotrophic lateral sclerosis. Patients and investigator were double-blinded. Clinical efficacy was determined using the Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatment Scale (ALS-SSIT) and the Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R), together with tests of limb muscle strength using the manual muscle test (MMT), forced vital capacity (FVC), and clinical chemistry laboratory tests over a 20-week observation period.
Results: The scores of ALS-SSIT in the BSJP group increased significantly (22%) after treatment. The ALSFRS-R score in the BSJP group decreased significantly after treatment (19%). The rate of decrease in muscle function (MMT score) in most BSJP patients was lower than that in the control group, where the differences in the scores for the trapezius and triceps brachii were statistically significant compared to the control group. The fall in FVC in the BJSP group was significantly slower than in the control group. There were no marked differences observed in the frequency of side effects. Serum vitamin D3 levels in the BSJP group showed greater increases compared to the control group.
Conclusion: BSJP treatment reduced the rate of progression of amyotrophic lateral sclerosis according to the ALS-SSITS and ALSFRS scores and significantly reduced the rate of deterioration in muscle function in the limbs of amyotrophic lateral sclerosis patients. The modes of action of BSJP in treating amyotrophic lateral sclerosis are probably diverse and multi targeted, some of which may involve regulation of serum vitamin D3 and alleviation of the impairments in liver and kidney function.Correspondence to:
Dr. Jun Wang
and
Professor Weidong Pan
Department of Neurology, Shuguang Hospital
Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, China
Email: [email protected]; [email protected]
Original
Expression of the genes QPRT, RAB26, and SRPRB in cancer tissue from patients with triple-negative breast cancer as a biomarker for diagnosis, pharmacotherapy strategy, and survival: Evidence from bioinformatic database analysis
Yarui Liu and Ying Zeng
Price
42.00 $
Volume 63 (2025) p. 575 - 583
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 12/2025 (575-583)
Expression of the genes QPRT, RAB26, and SRPRB in cancer tissue from patients with triple-negative breast cancer as a biomarker for diagnosis, pharmacotherapy strategy, and survival: Evidence from bioinformatic database analysis
Yarui Liu1 and Ying Zeng2
1Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, and 2Department of Pharmacy, The Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha, China
Objective: To screen differentially expressed genes (DEGs) in triple-negative breast cancer (TNBC) by bioinformatic methods and explore their relationship between TNBC prognosis and related biological functions.
Materials and methods: Microarray dataset GSE65194 was downloaded from Gene Expression Omnibus (GEO) database. The whole TNBC-related datasets were downloaded from The Cancer Genome Atlas (TCGA) database. After screening DEGs in R software, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were performed to predict the function of these DEGs. The survival curve examination of the DEGs was performed based on TCGA database and Kaplan–Meier plotter website. In addition, the gene-drug interaction network was explored using the Comparative Toxicogenomics Database (CTD).
Results: A total of 2,496 up-regulated and 142 down-regulated DEGs were revealed in GEO database and TCGA database simultaneously. The GO and KEGG analysis revealed enrichment in regulation of nucleobase, nucleoside, nucleic acid metabolism, DNA binding, and integrin family cell surface interactions. Furthermore, up-regulation of quinolinate phosphoribosyl transferase (QPRT), member RAS oncogene family (RAB26), and SRP receptor subunit beta (SRPRB) were significantly associated with survival in TNBC patients. Conclusion: QPRT, RAB26, and SRPRB may be three potential novel prognostic biomarkers for TNBC and will provide potential guidance value for future research on TNBC.Correspondence to:
Ying Zeng, PhD
Department of Pharmacy
The Affiliated Changsha Central Hospital
Hengyang Medical School
University of South China
Changsha 410028, China
Email: [email protected]
Original
Gastrointestinal symptoms in Parkinson’s disease treated in a controlled trial using traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) with network pharmacology analysis of active agents and mechanism of action
Shi Kay Loong, Feifei Wu, Yizhou Liu, Napattharin Voratunyakit, Shangyu Wei, Wei Li, Rui Li and Weidong Pan
Price
42.00 $
Volume 64 (2026) p. 369 - 383
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 7/2026 (369-383)
Gastrointestinal symptoms in Parkinson’s disease treated in a controlled trial using traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) with network pharmacology analysis of active agents and mechanism of action
Shi Kay Loong1*, Feifei Wu2*, Yizhou Liu1*, Napattharin Voratunyakit1, Shangyu Wei1, Wei Li1, Rui Li4 and Weidong Pan1#3#4
1Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of TCM, 2Department of Neurology, Shanghai Pudong New Area Gongli Hospital, 3Department of Neurology, Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, and 4Department of Neurology, Anhui Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Hefei, Anhui Province, China
Background: Gastrointestinal symptoms in Parkinson’s disease (PD), in particular chronic constipation, are common and are treated in China using the traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) (JWJCJ)). However, information on therapeutic targets and the underlying mechanism is limited.
Materials and methods: A total of 72 PD patients with constipation attending Departments of Neurology in Shanghai, China (Shanghai Pudong New Area Gongli Hospital and Shuguang Hospital Affiliated to Shanghai University) were recruited into the study and allocated to a Treatment group (n = 36) and a Control group (n = 36). Patients in the Control group received a combination treatment comprising anti-Parkinson agents (Western drug regimen) with the addition of a traditional Chinese patent medicine (Huang-Xing Run-Chang Tablets*) over a period of 5 weeks, whereas patients in the Treatment group received the same anti-PD Western drug regimen together with the JWJCJ decoction, also for a period of 5 weeks. An evaluation using clinical efficacy scores was carried out together with network pharmacology analysis. Identified drug targets for JWJCJ using the traditional Chinese medicine Swiss Target Prediction database (TCMSP) and disease targets for chronic constipation in PD were obtained from Genecards and the OMIM database. Therapeutic targets for JWJCJ in the treatment of chronic constipation were identified by intersecting drug targets and disease targets. GO functional enrichment analysis, KEGG pathway analysis, and disease association analysis were carried out using the DAVID database and visualized using Cytoscape 3.9.1 software.
Results: CSS efficacy scores in the Treatment group were higher than that in the Control group (88.57 vs. 52.94%, p < 0.001). No significant differences were seen prior to treatment in the CSS, PDQ-39 and MDS-UPDRS scores and the corresponding total scores for the two groups. After treatment, CSS values for patients in the Treatment group were higher than values before treatment (p < 0.01). Network pharmacology analysis identified 172 active components, 9,542 drug targets, and 421 intersecting target genes for JWJCJ. PPI analysis identified 10 main and possibly key targets for JWJCJ in the treatment of chronic constipation. KEGG analysis identified 198 signaling pathways, where pathways in cancer, specific cancer pathways such as prostate cancer and non-small cell lung cancer, lipid and atherosclerosis, hepatitis B, and the AGE-RAGE signaling pathway in diabetic complications were among the pathways most significantly enriched. These findings are evidence that the active ingredients in JWJCJ in the treatment of chronic constipation in PD mainly target TP53, SRC, AKT1, PIK3R1, and PIK3CA.
Conclusion:/b> The efficacy of JWJCJ in treating chronic constipation in PD involves the targets SRC, PIK3R1, JUN, TP53, STAT3, PIK3CA, EGFR, ESR1, MAPK1, and AKT1 domains. These findings provide theoretical basis for the clinical application of JWJCJ decoction in the treatment of chronic constipation in PD.
*Co-first authors.Correspondence to:
Dr. Rui Li
Department of Neurology
Anhui Branch of Shuguang Hospital
Affiliated to Shanghai University of Traditional Chinese Medicine
Hefei, Anhui Province, 230031 China
and
Professor Weidong Pan
Department of Neurology
Shuguang Hospital Affiliated to Shanghai
University of Traditional Chinese Medicine
Shanghai 201203, China
Email: [email protected]; [email protected]
