Trials / Completed
CompletedNCT02704702
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Boryung Pharmaceutical Co., Ltd · Industry
- Sex
- Male
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.
Detailed description
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fimasartan | |
| DRUG | Rosuvastatin | |
| DRUG | Fimasartan + Rosuvastatin |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-03-10
- Last updated
- 2018-11-02
- Results posted
- 2018-11-02
Source: ClinicalTrials.gov record NCT02704702. Inclusion in this directory is not an endorsement.