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Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013155
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablet under fed conditions

Condition Intervention
Essential Hypertension Drug: perindopril erbumine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 20 Days ]

Enrollment: 48
Study Start Date: May 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: perindopril erbumine
    8 mg tablet
    Other Name: Aceon
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to Perindopril or any comparable or similar product.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013155


Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
  More Information

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01013155     History of Changes
Other Study ID Numbers: PERI-T8-PVFD-1
First Submitted: November 11, 2009
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents