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Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®

NCT06073600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-25

No results posted yet for this study

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.

Conditions

  • Fed Conditions

Interventions

DRUG

Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®)

The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).

DRUG

Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg)

The subjects randomly received a single oral administration of Metformin / Vildagliptin Film Coated Tablets (1000 mg / 50 mg).

Sponsors & Collaborators

  • La Société Arabe des Industries Pharmaceutiques-Tunisie

    collaborator UNKNOWN

  • Centre National Chalbi Belkahia de Pharmacovigilance-Tunisie

    collaborator UNKNOWN

  • Reseach Laboratory of Clinical and Experimental Pharmacology

    lead NETWORK

Principal Investigators

  • Sameh Trabelsi · Research Laboratory of Clinical and experimental Pharmacology LR16SP02

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-09-09
Completion
2022-11-13

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073600 on ClinicalTrials.gov