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Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet

NCT02217670 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-01-20

No results posted yet for this study

Summary

The main purpose of this study is to assess comparative bioavailability of a test formulation of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) relative to Glucophage 1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects under fed conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.

Conditions

  • Comparative Bioavailability

Interventions

DRUG

Metformin 1000 mg granules

DRUG

Metformin 1000 mg film-coated tablets

Sponsors & Collaborators

  • Disphar International B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Primary Completion
2016-01-31

Countries

  • Jordan

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 NCT02217670 on ClinicalTrials.gov