Who is sponsoring NCT06103747?

NCT06103747 is sponsored by Reseach Laboratory of Clinical and Experimental Pharmacology.

What condition does NCT06103747 study?

NCT06103747 studies Fed Conditions.

What drugs are being tested in NCT06103747?

Interventions: Metformin / Vildagliptin Film Coated Tablets (850 mg / 50 mg), Galvumet® Film Coated Tablets (850 mg / 50 mg).

What is the status of NCT06103747?

NCT06103747 is currently COMPLETED.

Last reviewed 2023-10-27 · How we verify

Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®

NCT06103747 PHASE1 COMPLETED

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

Details

Lead sponsor	Reseach Laboratory of Clinical and Experimental Pharmacology
Phase	PHASE1
Status	COMPLETED
Enrolment	18
Start date	Tue Feb 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Fed Conditions

Interventions

Metformin / Vildagliptin Film Coated Tablets (850 mg / 50 mg)
Galvumet® Film Coated Tablets (850 mg / 50 mg)

Countries

Tunisia