Chinese- and French-Manufactured Immediate-Release Glucophage^® Bioequivalence: A Randomized, Open-Label, Crossover Study.

ABSTRACT:

Objective

We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured Glucophage^® immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer.

Methods

This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time (AUC_t) and maximum observed concentration (C_max).

Results

In total, 96 subje

SUBMITTER: Hu C 

PROVIDER: S-EPMC9700552 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature