NCT05688085

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

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan High/Amlodipine 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 High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2022-10-18
• Primary completion: 2022-12-29
• Completion: 2023-04-21
• First posted: 2023-01-18
• Last updated: 2023-08-18

Locations

1 site across 1 country: South Korea