Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®
Status:
Completed
Trial end date:
2023-08-15
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 (850 mg as metformin hydrochloride / 50 mg as
vildagliptin) manufactured by SAIPH versus the reference product Galvumet® tablets (850 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 in 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 CNPV - Tunisia Société Arabe des Industries Pharmaceutiques SAIPH - Tunisia