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

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

• Male 19-50 years of age.
• Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
• Medically healthy with no clinically significant medical history.
• Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion criteria

• History or presence of clinically significant medical or psychiatric condition or disease.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
• Plasma donation within a month prior to the first dose of study drug.
• Participation in another clinical trial within 3 months prior to the first dose of study drug(s).