Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
- Registration Number
- NCT03629067
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- A healthy adults aged 19-50 years
Exclusion Criteria
- History or presence of clinically significant medical or psychiatric condition or disease
- Hypersensitivity to ingredient of IP and other medication, food
- Participation in any other study within 3months
- History of whole blood donation within 2months and Apheresis 1month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A Treatment T Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period. Sequence A Treatment R Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period. Sequence B Treatment T Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period. Sequence C Treatment T Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period. Sequence C Treatment R Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period. Sequence B Treatment R Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period.
- Primary Outcome Measures
Name Time Method Cmax 0~144hours after Medication Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
- Secondary Outcome Measures
Name Time Method AUCinf 0~144hours after medication "Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Jongno-gu, Korea, Republic of