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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014