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

Handok

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Amlodipine; Drug: Irbesartan High/Amlodipine FDC; Drug: Irbesartan High

Study type: Interventional

Funder types: Industry

Identifiers

NCT05688085

HD-AI-103

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Irbesartan High/Amlodipine Fixed dose combination

Experimental group

Description:

participants will receive one tablet of Irbesartan High/Amlodipine FDC in a crossover design

Treatment:

Drug: Irbesartan High/Amlodipine FDC

Co-administration of Irbesartan High and Amlodipine

Experimental group

Description:

participants will receive one table each of Irbesartan High and Amlodipine in a crossover design

Treatment:

Drug: Irbesartan High

Drug: Amlodipine