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Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702091
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
June 19, 2008
June 20, 2008
June 20, 2008
January 2005
January 2005   (Final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, two-period, 7 day washout ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fasting conditions.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
Drug: Ramipril
10 mg capsule
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2005
January 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00702091
RAMI-C10-PVFS-1
No
Not Provided
Not Provided
Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Daniel V Freeland, D.O. CEDRA Clinical Research, LLC
Roxane Laboratories
June 2008

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