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
Overview
- Phase
- Phase 1
- Intervention
- Fimasartan/Amlodipine combination drug, Rosuvastatin
- Conditions
- Hypertension, Hyperlipidemia
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 60
- Primary Endpoint
- Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin
Intervention: Fimasartan/Amlodipine combination drug, Rosuvastatin
2
Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin
Intervention: Fimasartan/Amlodipine combination drug, Rosuvastatin
Outcomes
Primary Outcomes
Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
Time Frame: 0~72 hour after medication
AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
Time Frame: 0~72 hour after medication