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NCT05663073 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05663073
Other study ID # HD-AI-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 13, 2022
Est. completion date April 21, 2023

Study information
Verified date August 2023
Source Handok Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date April 21, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients who are 19 years or older on screening - Signed informed consent - Healthy Volunteer - Other inclusion applies Exclusion Criteria: - Clinically relevant/significant findings as evaluated by the investigator - Other exclusion applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Irbesartan/Amlodipine FDC
Irbesartan/Amlodipine FDC
• Irbesartan
Co-administration of Irbesartan and Amlodipine
• Amlodipine
Co-administration of Irbesartan and Amlodipine

Locations
Country Name City State
Korea, Republic of H Plus Yangji Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt of Irbesartan and Amlodipne 72 hours
Primary Cmax of Irbesartan and Amlodipne 72 hours
Secondary AUCinf of Irbesartan and Amlodipine 72 hours
Secondary AUCt/AUCinf of Irbesartan and Amlodipine 72 hours
Secondary tmax of Irbesartan and Amlodipine 72 hours
Secondary half-life of Irbesartan and Amlodipine 72 hours
Secondary CL/F of Irbesartan and Amlodipine 72 hours
Secondary Vz/F of Irbesartan and Amlodipine 72 hours
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