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

NCT ID: NCT05663073

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-04-21

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Irbesartan/Amlodipine Fixed dose combination

participants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design

Group Type EXPERIMENTAL

Irbesartan/Amlodipine FDC

Intervention Type DRUG

Irbesartan/Amlodipine FDC

Co-administration of Irbesartan and Amlodipine

participants will receive one table each of Irbesartan and Amlodipine in a crossover design

Group Type EXPERIMENTAL

Irbesartan

Intervention Type DRUG

Co-administration of Irbesartan and Amlodipine

Amlodipine

Intervention Type DRUG

Co-administration of Irbesartan and Amlodipine

Interventions

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Irbesartan/Amlodipine FDC

Irbesartan/Amlodipine FDC

Intervention Type DRUG

Irbesartan

Co-administration of Irbesartan and Amlodipine

Intervention Type DRUG

Amlodipine

Co-administration of Irbesartan and Amlodipine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H Plus Yangji Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HD-AI-101

Identifier Type: -

Identifier Source: org_study_id

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