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

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ClinicalTrials.gov Identifier: NCT00913887
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Study Start Date : April 1994
Primary Completion Date : May 1994
Study Completion Date : May 1994

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 32 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913887


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

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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action