Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®
Status:
Completed
Trial end date:
2022-11-13
Target enrollment:
Participant gender:
Summary
The aim of this study is to assess bioequivalence between a single oral dose from the test
product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as
vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the
reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as
vildagliptin) manufactured by Novartis.
This study also aims to monitor the safety of the subjects. This study is an open label,
randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover
study with a washout interval of at least one week between dosing.
Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy
volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within
the accepted limits for body height & weight and meeting the selection criteria for this
study.
Phase:
Phase 1
Details
Lead Sponsor:
Reseach Laboratory of Clinical and Experimental Pharmacology
Collaborators:
Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie La Société Arabe des Industries Pharmaceutiques-Tunisie