Trials / Withdrawn
WithdrawnNCT02217670
Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Disphar International B.V. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin 1000 mg granules | |
| DRUG | Metformin 1000 mg film-coated tablets |
Timeline
- Primary completion
- 2016-01-01
- First posted
- 2014-08-15
- Last updated
- 2016-01-20
Locations
1 site across 1 country: Jordan
Source: ClinicalTrials.gov record NCT02217670. Inclusion in this directory is not an endorsement.