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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP0912 / Irbesartan and Atorvastatin

• Registration Number: NCT01447797
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Last Update Submitted: 2012-04-01
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCP0912	HCP0912 / Irbesartan and Atorvastatin	Irbesartan/Atorvastatin combination tablet
Irbesartan and Atorvastatin	HCP0912 / Irbesartan and Atorvastatin	coadministration of irbesartan and atorvastatin

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of