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Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)

NCT05798715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-05

No results posted yet for this study

Summary

Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp \& Dohme, The Netherlands)

Conditions

  • Healthy

Interventions

DRUG

Gleptomet 50/1000(Metformin HCl & Sitagliptin)

Test drug

DRUG

Janumet 50/1000(Metformin HCl & Sitagliptin)

Reference drug

Sponsors & Collaborators

  • Eva Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2022-12-13
Completion
2023-01-13

Countries

  • Egypt

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 NCT05798715 on ClinicalTrials.gov