A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Phase 1
Completed
- Conditions
- Hypertension, Hyperlipidemia
- Interventions
- Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin
- Registration Number
- NCT02995720
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
- Healthy male subject, aged 19- 50 years
Exclusion Criteria
- History of clinically significant hypersensitivity to study drug, any other drug
- Hypotension or hypertension
- Active liver disease
- History of gastrointestinal disease
- History of excessive alcohol abuse
- Participation in any other study within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Fimasartan/Amlodipine combination drug, Rosuvastatin A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin 2 Fimasartan/Amlodipine combination drug, Rosuvastatin Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin
- Primary Outcome Measures
Name Time Method Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin 0~72 hour after medication AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin 0~72 hour after medication
- Secondary Outcome Measures
Name Time Method