To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913887
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.


Condition Intervention Phase
Inflammation
Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
Drug: Voltaren 75 mg Tablets Under Fed Conditions (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 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 32 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: April 1994
Study Completion Date: May 1994
Primary Completion Date: May 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
Experimental: 2
Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
Active Comparator: 3
Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

  Eligibility

Ages Eligible for Study:   18 Years to 40 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913887

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913887     History of Changes
Other Study ID Numbers: B-04124
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014