A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Drug: Fimasartan/Amlodipine
- Registration Number
- NCT02920047
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A Fimasartan + Amlodipine Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period. Sequence A Fimasartan/Amlodipine Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period. Sequency C Fimasartan/Amlodipine Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period. Sequency C Fimasartan + Amlodipine Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period. Sequence B Fimasartan/Amlodipine Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period. Sequence B Fimasartan + Amlodipine Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period.
- Primary Outcome Measures
Name Time Method Cmax and AUClast of Fimasartan, Amlodipine Time Frame: 0~144 hour after medication
- Secondary Outcome Measures
Name Time Method