To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913224
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.


Condition Intervention Phase
Inflammation
Drug: Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Drug: Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
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 Diclofenac Sodium 50 mg Enteric-Coated Tablets

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: April 1993
Study Completion Date: April 1993
Primary Completion Date: April 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Drug: Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
Active Comparator: 2
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
Drug: Voltaren 50 mg Tablets (Geigy Pharmaceuticals)

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Male
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913224

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Paul D. Larsen, M.D. Red River Clinic
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913224     History of Changes
Other Study ID Numbers: B-03113
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Anti-inflammatory

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014