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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Irbesartan/Amlodipine High FDC; Drug: Irbesartan; Drug: Amlodipine High

• Registration Number: NCT05688098
• Lead Sponsor: Handok Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Primary Completion: 2022-11-24
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Study Completion: 2023-04-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Co-administration of Irbesartan and Amlodipine High	Amlodipine High	participants will receive one table each of Irbesartan and Amlodipine High in a crossover design
Irbesartan/Amlodipine High Fixed dose combination	Irbesartan/Amlodipine High FDC	participants will receive one tablet of Irbesartan/Amlodipine High FDC in a crossover design
Co-administration of Irbesartan and Amlodipine High	Irbesartan	participants will receive one table each of Irbesartan and Amlodipine High in a crossover design

Primary Outcome Measures

Name	Time	Method
AUCt of Irbesartan and Amlodipne High	72 hours
Cmax Irbesartan and Amlodipne High	72 hours

Secondary Outcome Measures

Name	Time	Method
AUCt/AUCinf of Irbesartan and Amlodipine High	72 hours
half-life of Irbesartan and Amlodipine High	72 hours
AUCinf of Irbesartan and Amlodipine High	72 hours
tmax of Irbesartan and Amlodipine High	72 hours
CL/F of Irbesartan and Amlodipine High	72 hours
Vz/F of Irbesartan and Amlodipine High	72 hours

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of