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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946465
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Ramipril 10 Capsule (Sandoz)
Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)
 Phase 1

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 Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Ramipril
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ramipril 10 Capsule (Sandoz)
 Drug: Ramipril 10 Capsule (Sandoz)
Active Comparator: 2
Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)
 Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946465

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Steven Herrmann, M.D., PhD Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946465     History of Changes
Other Study ID Numbers: B043723
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

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 May 22, 2013