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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: HCP0912 / Irbesartan and Atorvastatin (Drug)

Phase: Phase 1

Status: Completed

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

Summary

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

Clinical Details

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

Eligibility

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

Locations and Contacts

Korea University Anam Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: September 2011
Last updated: April 1, 2012

Page last updated: August 23, 2015

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