To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946621
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 24, 2009
July 24, 2009
October 2004
November 2004   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Ramipril 10 mg Capsule (Sandoz)
  • Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
  • Experimental: 1
    Ramipril 10 mg Capsule (Sandoz)
    Intervention: Drug: Ramipril 10 mg Capsule (Sandoz)
  • Active Comparator: 2
    Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
    Intervention: Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2004
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00946621
B043724
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Steven Herrmann, M.D., PhD Cetero Research, San Antonio
Sandoz
July 2009

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