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

Condition(s) targeted: Healthy

Intervention: HCP0912 / Irbesartan and Atorvastatin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Hanmi Pharmaceutical Company Limited

Official(s) and/or principal investigator(s):
Ji-Young Park, MD, PhD, Principal Investigator, Affiliation: Korea University Anam Hospital

Overall contact:
Kyung-Mi Park, PhD, Email: kmpark@hanmi.co.kr

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUC of Irbesartan

AUC of Atorvastatin and 2-hydroxy atorvastatin

Cmax of Irbesartan

Cmax of Atorvastatin and 2-hydroxy atorvastatin

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Kyung-Mi Park, PhD, Email: kmpark@hanmi.co.kr

Korea University Anam Hospital, Seoul, Korea, Republic of; Recruiting
Ji-Young Park, MD, PhD
Ji-Young Park, MD, PhD, Principal Investigator
Kyung-A Kim, MD, PhD, Sub-Investigator

Starting date: September 2011
Last updated: October 5, 2011