2024
DOI: 10.1002/cpdd.1369
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Bioequivalence and Safety Assessment of 2 Formulations of Low‐Dose Metformin Hydrochloride under Fasting Conditions in Healthy Chinese Participants: A Randomized Phase 1 Clinical Trial

Ming‐Li Sun,
Xin‐Wen Xu,
Chen Liu
et al.

Abstract: The incidence of type 2 diabetes is high, and the existing metformin hydrochloride (MH) tablets of 250 mg cannot meet the demands of the Chinese drug market. This study aimed to evaluate the bioequivalence and safety of generic formulations of MH tablets (test formulation [T], 250 mg/tablet) and innovative products (reference formulation [R], 250 mg/tablet) under fasting conditions. This was an open‐label, single‐dose, 2‐period, 2‐sequence crossover, single‐center, randomized phase I clinical trial. T and R we… Show more

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