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

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine High 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
NCT05688098
Enrollment
44
Registered
2023-01-18
Start date
2022-09-23
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 High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Interventions

DRUGIrbesartan/Amlodipine High FDC

Irbesartan/Amlodipine High FDC

DRUGIrbesartan

Co-administration of Irbesartan and Amlodipine High

DRUGAmlodipine High

Co-administration of Irbesartan and Amlodipine High

Sponsors

Handok Inc.
Lead SponsorINDUSTRY

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 applied

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
AUCt of Irbesartan and Amlodipne High72 hours
Cmax Irbesartan and Amlodipne High72 hours

Secondary

MeasureTime frame
tmax of Irbesartan and Amlodipine High72 hours
half-life of Irbesartan and Amlodipine High72 hours
AUCinf of Irbesartan and Amlodipine High72 hours
Vz/F of Irbesartan and Amlodipine High72 hours
CL/F of Irbesartan and Amlodipine High72 hours
AUCt/AUCinf of Irbesartan and Amlodipine High72 hours

Countries

South Korea

Outcome results

None listed

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