Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Drug-Drug Interaction
- Interventions
- Registration Number
- NCT03390465
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- A healthy Male 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 Arm1(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Arm2(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Arm3(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Arm4(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Arm5(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Arm6(N=6) Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
- Primary Outcome Measures
Name Time Method Cmax 0~48hours after medication Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
- Secondary Outcome Measures
Name Time Method AUCt 0~48hours after medication AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide
Trial Locations
- Locations (1)
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of