NCT05663073

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

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Irbesartan/Amlodipine FDC	Irbesartan/Amlodipine FDC
DRUG	Irbesartan	Co-administration of Irbesartan and Amlodipine
DRUG	Amlodipine	Co-administration of Irbesartan and Amlodipine

Timeline

• Start date: 2022-09-13
• Primary completion: 2022-12-15
• Completion: 2023-04-21
• First posted: 2022-12-23
• Last updated: 2023-08-18

Locations

1 site across 1 country: South Korea