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

Overview

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

Full Title of Study: “A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2004

Interventions

  • Drug: Ramipril 10 Capsule (Sandoz)
  • Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

Arms, Groups and Cohorts

  • Experimental: 1
    • Ramipril 10 Capsule (Sandoz)
  • Active Comparator: 2
    • Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on AUC and Cmax
    • Time Frame: 30 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
  • Overall Official(s)
    • Steven Herrmann, M.D., PhD, Principal Investigator, Cetero Research, San Antonio

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