To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Inflammation Clinical Trial

Official title:

A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914160
• Other study ID #: B-08133
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: March 27, 2017
• Start date: August 1993
• Est. completion date: September 1993

Study information

• Verified date: June 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 1993
• Est. primary completion date: September 1993
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)

• Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)

• Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		31 days