Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin
Phase 1
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02140489
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Healthy male
- Age between 19 and 55
- Signed informed consent
Exclusion Criteria
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 amosartan amosartan → rosuvastatin → amosartan and rosuvastatin Sequence 1 amosartan and rosuvastatin amosartan → rosuvastatin → amosartan and rosuvastatin Sequence 2 amosartan rosuvastatin → amosartan and rosuvastatin → amosartan Sequence 2 amosartan and rosuvastatin rosuvastatin → amosartan and rosuvastatin → amosartan Sequence 3 amosartan amosartan and rosuvastatin → amosartan → rosuvastatin Sequence 3 amosartan and rosuvastatin amosartan and rosuvastatin → amosartan → rosuvastatin Sequence 1 rosuvastatin amosartan → rosuvastatin → amosartan and rosuvastatin Sequence 2 rosuvastatin rosuvastatin → amosartan and rosuvastatin → amosartan Sequence 3 rosuvastatin amosartan and rosuvastatin → amosartan → rosuvastatin
- Primary Outcome Measures
Name Time Method Cmax 0-72h AUClast 0-72h
- Secondary Outcome Measures
Name Time Method AUCinf 0-72h tmax 0-72h t1/2 0-72h
Trial Locations
- Locations (1)
Samgsung Seoul Hospital
🇰🇷Seoul, Korea, Republic of