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OpenTrials
Completed

NCT Number: NCT01447797

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP0912 / Irbesartan and Atorvastatin

Drug

Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin

Primary outcomes

  1. AUC of Irbesartan

    Time frame: 0-48 hrs

  2. AUC of Atorvastatin and 2-hydroxy atorvastatin

    Time frame: 0-48 hrs

  3. Cmax of Irbesartan

    Time frame: 0-48 hrs

  4. Cmax of Atorvastatin and 2-hydroxy atorvastatin

    Time frame: 0-48 hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2011
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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