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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05663073

Enrollment

Registered

2022-12-23

Start date

2022-09-13

Completion date

2023-04-21

Last updated

2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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

Interventions

DRUGIrbesartan/Amlodipine FDC

Irbesartan/Amlodipine FDC

DRUGIrbesartan

Co-administration of Irbesartan and Amlodipine

DRUGAmlodipine

Co-administration of Irbesartan and Amlodipine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCt of Irbesartan and Amlodipne	72 hours
Cmax of Irbesartan and Amlodipne	72 hours

Secondary

Measure	Time frame
tmax of Irbesartan and Amlodipine	72 hours
half-life of Irbesartan and Amlodipine	72 hours
AUCinf of Irbesartan and Amlodipine	72 hours
Vz/F of Irbesartan and Amlodipine	72 hours
CL/F of Irbesartan and Amlodipine	72 hours
AUCt/AUCinf of Irbesartan and Amlodipine	72 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026