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

September 28, 2011
April 1, 2012
September 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01447797 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: HCP0912 / Irbesartan and Atorvastatin
Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin
  • Experimental: HCP0912
    Irbesartan/Atorvastatin combination tablet
    Intervention: Drug: HCP0912 / Irbesartan and Atorvastatin
  • Active Comparator: Irbesartan and Atorvastatin
    coadministration of irbesartan and atorvastatin
    Intervention: Drug: HCP0912 / Irbesartan and Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01447797
HM-IBAT-104
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Ji-Young Park, MD, PhD Korea University Anam Hospital
Hanmi Pharmaceutical Company Limited
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP