Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00702260
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: June 19, 2008
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014