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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: June 2, 2009
Last updated: March 27, 2017
Last verified: June 2009
To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.

Condition Intervention Phase
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
Intervention Model: Crossover Assignment
Masking: No masking
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 ]

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)


Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00913224

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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00913224     History of Changes
Other Study ID Numbers: B-03113
Study First Received: June 2, 2009
Last Updated: March 27, 2017

Keywords provided by Sandoz:

Additional relevant MeSH terms:
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017