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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCP0912

Irbesartan/Atorvastatin combination tablet

Group Type EXPERIMENTAL

HCP0912 / Irbesartan and Atorvastatin

Intervention Type DRUG

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

Irbesartan and Atorvastatin

coadministration of irbesartan and atorvastatin

Group Type ACTIVE_COMPARATOR

HCP0912 / Irbesartan and Atorvastatin

Intervention Type DRUG

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

Interventions

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HCP0912 / Irbesartan and Atorvastatin

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes