A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

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

Details

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

Criteria

Inclusion Criteria:

1. Caucasian male 19-55 years of age.

2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.

3. Medically healthy with no clinically significant medical history.

4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.

2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.

4. Plasma donation within 7 days prior to the first dose of study drug.

5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).