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

Boryung

Status and phase: Completed; Phase 1

Conditions: Drug-Drug Interaction

Treatments: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390465

BR1010

Details and patient eligibility

About

The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Enrollment: 36 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Arm1(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm2(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm3(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm4(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm5(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm6(N=6)

Other group

Description:

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Treatment:

Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide