Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers

Handok Inc.46 enrolled

Overview

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Irbesartan/Amlodipine FDCDRUG

Irbesartan/Amlodipine FDC

IrbesartanDRUG

Co-administration of Irbesartan and Amlodipine

AmlodipineDRUG

Co-administration of Irbesartan and Amlodipine

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are 19 years or older on screening * Signed informed consent * Healthy Volunteer * Other inclusion applies Exclusion Criteria: * Clinically relevant/significant findings as evaluated by the investigator * Other exclusion applied

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUCt of Irbesartan and Amlodipne

Time frame: 72 hours

Cmax of Irbesartan and Amlodipne

Time frame: 72 hours

Secondary Outcomes

AUCinf of Irbesartan and Amlodipine

Time frame: 72 hours

AUCt/AUCinf of Irbesartan and Amlodipine

Time frame: 72 hours

tmax of Irbesartan and Amlodipine

Time frame: 72 hours

half-life of Irbesartan and Amlodipine

Time frame: 72 hours

CL/F of Irbesartan and Amlodipine

Time frame: 72 hours

Vz/F of Irbesartan and Amlodipine

Time frame: 72 hours

Data from ClinicalTrials.gov

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