An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

NCT02397538 Phase 1 COMPLETED

An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Details

Lead sponsor	Boryung Pharmaceutical Co., Ltd
Phase	Phase 1
Status	COMPLETED
Enrolment	50
Start date	2015-02
Completion	2015-04

Conditions

• Hypertension

Interventions

• Fimasartan
• Amlodipine
• Rosuvastatin

Primary outcomes

• Cmax,ss — Time Frame: 0~24 hour after medication
  When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin
• AUC tau,ss — Time Frame: 0~24 hour after medication
  When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin

Countries

South Korea