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NCT03390465 Clinical Trial

Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Drug-Drug Interaction Clinical Trial

Official title:
An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03390465
Other study ID # BR1010
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 15, 2017
Est. completion date January 30, 2018

Study information
Verified date August 2018
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 Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 30, 2018
Est. primary completion date January 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Locations
Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busan

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 0~48hours after medication
Secondary AUCt AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide 0~48hours after medication
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