A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

• Status: Completed
• Trial end date: 2017-05-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Amlodipine; Rosuvastatin Calcium

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