Trials / Completed
CompletedNCT03809260
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- Male
- Age
- 19 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin (part 1) | 1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d\~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch). |
| DRUG | Vancomycin | 11d: Vancomycin 250 mg bid, 12\~17d: Vancomycin 500 mg bid |
| DRUG | Metformin (part 2) | 1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch) |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
- First posted
- 2019-01-18
- Last updated
- 2020-10-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03809260. Inclusion in this directory is not an endorsement.