Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Boryung

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Treatment R; Drug: Treatment T

Study type: Interventional

Funder types: Industry

Identifiers

NCT03629067

BR1010(BR-FAHC-CT-102)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Sequence A

Experimental group

Description:

Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period.

Treatment:

Drug: Treatment T

Drug: Treatment R

Sequence B

Experimental group

Description:

Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period.

Treatment:

Drug: Treatment T

Drug: Treatment R

Sequence C

Experimental group

Description:

Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period.

Treatment:

Drug: Treatment T

Drug: Treatment R