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

Handok Inc.44 enrolled

Overview

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine High 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 High FDCDRUG

Irbesartan/Amlodipine High FDC

IrbesartanDRUG

Co-administration of Irbesartan and Amlodipine High

Amlodipine HighDRUG

Co-administration of Irbesartan and Amlodipine High

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 applied 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 High

Time frame: 72 hours

Cmax Irbesartan and Amlodipne High

Time frame: 72 hours

Secondary Outcomes

AUCinf of Irbesartan and Amlodipine High

Time frame: 72 hours

AUCt/AUCinf of Irbesartan and Amlodipine High

Time frame: 72 hours

tmax of Irbesartan and Amlodipine High

Time frame: 72 hours

half-life of Irbesartan and Amlodipine High

Time frame: 72 hours

CL/F of Irbesartan and Amlodipine High

Time frame: 72 hours

Vz/F of Irbesartan and Amlodipine High

Time frame: 72 hours

Data from ClinicalTrials.gov

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