A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Overview
- Phase
- Phase 1
- Intervention
- Fimasartan/Amlodipine/Rosuvastatin
- Conditions
- Hypertension
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a 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
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Intervention: Fimasartan/Amlodipine/Rosuvastatin
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Intervention: Fimasartan/Amlodipine
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Intervention: Rosuvastatin
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Intervention: Fimasartan/Amlodipine/Rosuvastatin
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Intervention: Fimasartan/Amlodipine
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Intervention: Rosuvastatin
Outcomes
Primary Outcomes
AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
Time Frame: 0~144 hour after medication
Cmax of Fimasartan, Amlodipine and Rosuvastatin
Time Frame: 0~144 hour after medication