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

April 1, 2012 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCP0912
Irbesartan/Atorvastatin combination tablet
Drug: HCP0912 / Irbesartan and Atorvastatin
Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin
Active Comparator: Irbesartan and Atorvastatin
coadministration of irbesartan and atorvastatin
Drug: HCP0912 / Irbesartan and Atorvastatin
Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of Irbesartan
Time Frame: 0-48 hrs
0-48 hrs
AUC of Atorvastatin and 2-hydroxy atorvastatin
Time Frame: 0-48 hrs
0-48 hrs
Cmax of Irbesartan
Time Frame: 0-48 hrs
0-48 hrs
Cmax of Atorvastatin and 2-hydroxy atorvastatin
Time Frame: 0-48 hrs
0-48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Ji-Young Park, MD, PhD, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

April 1, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-IBAT-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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