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CompletedNCT05663073Updated Aug 18, 2023

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

A Phase 1 interventional study of Irbesartan/Amlodipine FDC and Irbesartan in Healthy Volunteers, sponsored by Handok Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Handok Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2022, registered Dec 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Handok Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients who are 19 years or older on screening
  • Signed informed consent
  • Healthy Volunteer
  • Other inclusion applies

Exclusion criteria

Exclusion Criteria:

  • Clinically relevant/significant findings as evaluated by the investigator
  • Other exclusion applied
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Irbesartan/Amlodipine Fixed dose combination

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

    Drug: Irbesartan/Amlodipine FDC

  • Experimental
    Co-administration of Irbesartan and Amlodipine

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

    Drug: Irbesartan · Drug: Amlodipine

Interventions

  • DrugIrbesartan/Amlodipine FDC

    Irbesartan/Amlodipine FDC

  • DrugIrbesartan

    Co-administration of Irbesartan and Amlodipine

  • DrugAmlodipine

    Co-administration of Irbesartan and Amlodipine

06

What researchers measure

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

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, 08779, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05663073
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Sep 13, 2022
Primary completion
Dec 15, 2022
Completion
Apr 21, 2023
Last update
Aug 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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