Trials / Completed
CompletedNCT04065581
Bioequivalence Study for Acarbose/Metformin FDC
Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and the Loose Combination of Acarbose and Metformin Following Single Oral Dosing in Chinese Healthy Adult Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acarbose/Metformin FDC(BAY81-9783) | Single dose: 50 mg acarbose/500 mg metformin tablet, oral |
| DRUG | Glucobay | Single dose: 50 mg tablet, oral |
| DRUG | Glucophage | Single dose: 500 mg tablet, oral |
Timeline
- Start date
- 2019-10-14
- Primary completion
- 2019-11-25
- Completion
- 2020-03-06
- First posted
- 2019-08-22
- Last updated
- 2020-04-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04065581. Inclusion in this directory is not an endorsement.