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

Handok

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05688098

HD-AI-102

Details and patient eligibility

About

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

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/Amlodipine High Fixed dose combination

Other group

Description:

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

Treatment:

Drug: Irbesartan/Amlodipine High FDC

Co-administration of Irbesartan and Amlodipine High

Other group

Description:

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

Treatment:

Drug: Irbesartan

Drug: Amlodipine High