NCT00913887

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 1994

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1994

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1994

Completed
15.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

March 28, 2017

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

June 2, 2009

Last Update Submit

March 27, 2017

Conditions

Inflammation

Keywords

Anti-Inflammatory

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    32 days

Study Arms (3)

1

EXPERIMENTAL

Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)

Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)

2

EXPERIMENTAL

Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)

Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)

3

ACTIVE COMPARATOR

Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Interventions

Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)DRUG
1
Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)DRUG
2
Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)DRUG
3

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Paul D. Larsen, M.D.

    Red River Clinical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

April 1, 1994

Primary Completion

May 1, 1994

Study Completion

May 1, 1994

Last Updated

March 28, 2017

Record last verified: 2009-06