A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin

Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01447797

Enrollment

Registered

2011-10-06

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2012-04-03

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

Conditions

Healthy

Keywords

Irbesartan, Atorvastatin, combination

Brief summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912

Interventions

DRUGHCP0912 / Irbesartan and Atorvastatin

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 20 and 45 * Signed informed consent form * weight : over 45kg and in the range of ±20% of IBW

Exclusion criteria

* Has a medical history of hypersensitivity to atorvastatin or irbesartan * severe Hypotension * Not eligible for subject in health examination within 28 days of IP administration

Design outcomes

Primary

Measure	Time frame
AUC of Irbesartan	0-48 hrs
AUC of Atorvastatin and 2-hydroxy atorvastatin	0-48 hrs
Cmax of Irbesartan	0-48 hrs
Cmax of Atorvastatin and 2-hydroxy atorvastatin	0-48 hrs

Countries

South Korea

Outcome results

None listed

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