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Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00702091
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 19, 2008
June 19, 2008
January 2005
January 2005   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, two-period, 7 day washout ] [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00702091
RAMI-C10-PVFS-1
No
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