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OpenTrials
Completed

NCT Number: NCT05663073

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

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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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, 08779, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan/Amlodipine FDC

Drug

Irbesartan/Amlodipine FDC

Irbesartan

Drug

Co-administration of Irbesartan and Amlodipine

Amlodipine

Drug

Co-administration of Irbesartan and Amlodipine

Primary outcomes

  1. AUCt of Irbesartan and Amlodipne

    Time frame: 72 hours

  2. Cmax of Irbesartan and Amlodipne

    Time frame: 72 hours

Secondary outcomes

  1. AUCinf of Irbesartan and Amlodipine

    Time frame: 72 hours

  2. AUCt/AUCinf of Irbesartan and Amlodipine

    Time frame: 72 hours

  3. tmax of Irbesartan and Amlodipine

    Time frame: 72 hours

  4. half-life of Irbesartan and Amlodipine

    Time frame: 72 hours

  5. CL/F of Irbesartan and Amlodipine

    Time frame: 72 hours

  6. Vz/F of Irbesartan and Amlodipine

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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