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 IrbesartanAUC 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
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