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Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702260
First Posted: June 20, 2008
Last Update Posted: June 20, 2008
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 Ramipril 10 mg capsules under fed conditions.

Condition Intervention
Hypertension Drug: Ramipril

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, two-period, 7 day washout ]

Enrollment: 39
Study Start Date: January 2005
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ramipril
    10 mg capsule
  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 Ramipril 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): NCT00702260


Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Daniel V Freeland, D.O. CEDRA Clinical Research
  More Information

Responsible Party: Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00702260     History of Changes
Other Study ID Numbers: RAMI-C10-PVFD-1
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: June 20, 2008
Last Verified: June 2008

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