NCT05688098

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (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 High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2022-09-23
• Primary completion: 2022-11-24
• Completion: 2023-04-21
• First posted: 2023-01-18
• Last updated: 2023-08-18

Locations

1 site across 1 country: South Korea