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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01447797
First received: September 28, 2011
Last updated: April 1, 2012
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HCP0912 / Irbesartan and Atorvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUC of Irbesartan [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]
  • AUC of Atorvastatin and 2-hydroxy atorvastatin [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]
  • Cmax of Irbesartan [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]
  • Cmax of Atorvastatin and 2-hydroxy atorvastatin [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447797

Locations
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Ji-Young Park, MD, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01447797     History of Changes
Other Study ID Numbers: HM-IBAT-104
Study First Received: September 28, 2011
Last Updated: April 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Irbesartan
Atorvastatin
combination

Additional relevant MeSH terms:
Atorvastatin
Irbesartan
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 14, 2014