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

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.

Inclusion Criteria:

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 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 100/65 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).