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 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean AUC_t and C_max (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80-125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity.

Conclusions

Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated.

Clinical trials registration

This study was registered at ClinicalTrials.gov under the identifying number NCT03393208.

SUBMITTER: Hu C 

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

REPOSITORIES: biostudies-literature