- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629067
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Jongno-gu
-
Seoul, Jongno-gu, Korea, Republic of, 100-744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence A
Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period. |
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
|
Experimental: Sequence B
Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period. |
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
|
Experimental: Sequence C
Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period. |
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 0~144hours after Medication
|
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
|
0~144hours after Medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCinf
Time Frame: 0~144hours after medication
|
"Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide
|
0~144hours after medication
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BR1010(BR-FAHC-CT-102)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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