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NCT03629067 Clinical Trial

Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Pharmacokinetics Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03629067
Other study ID # BR1010(BR-FAHC-CT-102)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 13, 2018
Est. completion date December 27, 2018

Study information
Verified date January 2019
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 27, 2018
Est. primary completion date November 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment T
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
• Treatment R
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma 0~144hours after Medication
Secondary AUCinf "Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide 0~144hours after medication
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