Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial

Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial

Background As per the National Medical Products Administration (NMPA) requirements, the quality and efficacy of generic drugs must be consistent with those of the innovator drug. We aimed to evaluate the bioequivalence and safety of generic metformin hydrochloride sustained-release (MH-SR) tablets (...

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Bibliographic Details
Main Authors: Ming-Li Sun, Chen Liu, Hai-Hong Bai, Ya-Li Wei, Wei Zhang, Hui-Juan Liu, Yin-Juan Li, Long Liu, Yu Wang, Yuan-Xv Tong, Qian Gao, Qian-Ying Liu, Xinghe Wang
Format: Article
Language:English
Published: Taylor & Francis Group 2022-12-01
Series:Annals of Medicine
Subjects:
Bioequivalence
crossover trials
metformin hydrochloride
pharmacokinetics
fasting conditions
Online Access:https://www.tandfonline.com/doi/10.1080/07853890.2022.2125574

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https://www.tandfonline.com/doi/10.1080/07853890.2022.2125574

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