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Books: 0	Journals: 2	Articles: 3

Original

Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects

Yan Wang, Jin Lu, Tengfei Li, Shunbo Zhao, Wen Yang, Lingye Liu, Xing Shi, and Li Ding

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Volume 56 (2018) p. 247 - 254

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 5/2018 (247-254)

Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects

Yan Wang¹#², Jin Lu³, Tengfei Li¹, Shunbo Zhao³, Wen Yang¹, Lingye Liu³, Xing Shi³, and Li Ding¹#³

¹Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, ²College of Pharmacy and Chemistry, Dali University, Dali, and  ³Nanjing Clinical Tech Laboratories Inc., Nanjing, China
Objectives: The aims of the study were to investigate the potential drug-drug interaction between salbutamol and ambroxol, the bioequivalence of the new fixed-dose combination containing salbutamol and ambroxol compared with co-administration of the two separate formulations, and to describe the safety and tolerability of the fixed-dose combination formulation in healthy Chinese volunteers. Materials and methods: An open-label, single-dose, four-treatment, four-period crossover study for evaluation of drug-drug interaction and bioequivalence (n = 24) was performed. Each participant received salbutamol 4 mg, ambroxol 15 mg, salbutamol 4 mg co-administered with ambroxol 15 mg or fixed-dose combination formulation (salbutamol 4 mg and ambroxol 15 mg). Plasma concentrations of two analytes were determined with the use of validated LC-MS/MS method. Safety and tolerability were assessed by recording adverse events. Results: Co-administration of salbutamol and ambroxol was not associated with a significant influence on single salbutamol or ambroxol pharmacokinetics. After statistical comparisons of log-transformed C_max and AUC of salbutamol and ambroxol between fixed-dose combination and concomitant treatments, all 90% confidence intervals of geometric mean ratios were within the predefined equivalence range of 80 – 125%. No serious adverse events were reported, and all treatments were safe and well tolerated in Chinese healthy subjects. Conclusion: There were no significant drug-drug pharmacokinetic interactions between salbutamol and ambroxol after oral administration. The new formulation was bioequivalent to the co-administration of two drugs in separate dosage forms. Correspondence to:
Li Ding, MD, PhD 
Department of  Pharmaceutical Analysis
China  Pharmaceutical University
 24 Tongjiaxiang,  Nanjing, 210009,  China 
Email: [email protected]

Original Research

Pharmacokinetics and safety of salbutamol/ambroxol fixed-dose combination granules in healthy Chinese subjects 

Yan Wang, Jin Lu, Tengfei Li, Shunbo Zhao, Wen Yang, Lingye Liu, Xing Shi, Mtalimanja Michael, and Li Ding

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42.00 $

Volume 56 (2018) p. 597 - 603

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 12/2018 (597-603)

Pharmacokinetics and safety of salbutamol/ambroxol fixed-dose combination granules in healthy Chinese subjects 

Yan Wang¹#², Jin Lu³, Tengfei Li¹, Shunbo Zhao³, Wen Yang¹, Lingye Liu³, Xing Shi³, Mtalimanja Michael¹, and Li Ding¹#³

¹Department of Pharmaceutical Analysis, China Pharmaceutical University,  Nanjing, ²College of Pharmacy and Chemistry, Dali University, Dali, and  ³Nanjing Clinical Tech Laboratories Inc., Nanjing, China
Objectives: The aim of the study was to investigate the pharmacokinetics and tolerability of salbutamol/ambroxol fixed-dose combination granules following single and multiple dosing in healthy Chinese subjects. Materials and methods: This was a randomized, open-label, two-period, one-sequence study (n = 12). Each subject received a single oral dose in period 1 and multiple doses in period 2. Plasma concentrations of these two components were determined using a validated LC-MS/MS method. Adverse events (AEs) were documented throughout the study. Investigators evaluated AEs in terms of frequency, duration, intensity, seriousness, outcome, and relationship to study drugs. Results: Following single dosing, C<sub>max</sub> values were 8.07 ± 1.31 ng/mL and 25.7 ± 6.5 ng/mL for salbutamol and ambroxol, respectively. The corresponding T<sub>1/2</sub> values were 8.15 ± 3.13 hours and 9.31 ± 2.27 hours, respectively. Moreover, no statistical differences in the pharmacokinetics of salbutamol and ambroxol in subjects receiving single or multiple dosage were observed. Single- and multiple-dose oral administration of fixed-dose combination granules were safe and well tolerated in healthy Chinese subjects. Drug hypersensitivity syndrome did not occur during our study. Conclusion: The pharmacokinetics of salbutamol and ambroxol in the fixed-dose combination granules were not affected by dosing duration, and gender differences seemed to have no effect on the pharmacokinetics of salbutamol and ambroxol after a single dose and multiple doses of the medication. Correspondence to:
Li Ding, MD, PhD
Department of  Pharmaceutical Analysis
China  Pharmaceutical University
24 Tongjiaxiang, Nanjing, 210009, China 
Email: [email protected]

Original

Associations between atherogenic index of plasma and chronic kidney disease in individuals with hypertension, diabetes mellitus, and hyperuricemia 

Ye Li, Yu-Xuan Zhu, Yi Qiu, and Ya-Yu Li

Volume 105 (2026) p. 117 - 127

Abstract

Clinical Nephrology, Vol. 105 – No. 2/2026 (117-127)

Associations between atherogenic index of plasma and chronic kidney disease in individuals with hypertension, diabetes mellitus, and hyperuricemia 

Ye Li¹, Yu-Xuan Zhu¹, Yi Qiu², and Ya-Yu Li²

¹Department of Nephrology, Hangzhou TCM Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, and ²Key Laboratory of Kidney Disease Prevention and Control Technology, Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang Province, China
Objective: The association between the atherogenic index of plasma (AIP) and chronic kidney disease (CKD) among individuals with different metabolic syndromes remains inadequately characterized. The aim of this study is to assess the correlations between AIP and the risk of CKD among individuals diagnosed with hypertension (HTN), diabetes mellitus (DM), and hyperuricemia (HUA).
Materials and methods: Data from the National Health and Nutrition Examination Survey, collected between 2009 and March 2020, were used to categorize eligible participants into HTN, DM, and HUA groups. Weighted logistic regression models and restricted cubic splines were employed to examine the correlations between AIP and CKD. The incremental predictive value of AIP, compared with conventional CKD risk factors, was assessed using the area under the curve, net reclassification improvement index, and integrated discrimination improvement.
Results: Among individuals in the HTN and DM groups, an increase of one unit in AIP was associated with a 17% increase in the risk of CKD (odds ratio (OR): 1.17, 95% confidence interval (CI): 1.10 – 1.25) and a 29% increase (OR: 1.29, 95% CI: 1.18 – 1.40), respectively. Conversely, within the HUA group, neither persistent AIP nor any of the three AIP levels demonstrated a statistically significant correlation with CKD.
Conclusion: The findings demonstrated a significant association between AIP and CKD in individuals with HTN and DM, indicating a potential link between dyslipidemia and CKD risk within these populations. In contrast, AIP did not exhibit a significant association with CKD among individuals with HUA.Correspondence to:
Ya-Yu Li, PhD
Key Laboratory of Kidney Disease Prevention and Control Technology
Department of Nephrology
Hangzhou Hospital of Traditional Chinese Medicine
No. 453 of Tiyuchang Road, Xihu District
Hangzhou 310012, Zhejiang Province, China
Email: [email protected]

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