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

August 15, 2023 updated by: Handok Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irbesartan High/Amlodipine Fixed dose combination
participants will receive one tablet of Irbesartan High/Amlodipine FDC in a crossover design
Drug: Irbesartan High/Amlodipine FDC
Irbesartan High/Amlodipine FDC
Experimental: Co-administration of Irbesartan High and Amlodipine
participants will receive one table each of Irbesartan High and Amlodipine in a crossover design
Drug: Irbesartan High
Co-administration of Irbesartan High and Amlodipine
Drug: Amlodipine
Co-administration of Irbesartan High and Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
Cmax of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
AUCt/AUCinf of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
tmax of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
half-life of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
CL/F of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours
Vz/F of Irbesartan High and Amlodipine
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-AI-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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