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Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel

NCT01202799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-09-23

No results posted yet for this study

Summary

It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).

Conditions

Interventions

DRUG

2% w/w diclofenac sodium topical gel

2% w/w diclofenac sodium topical gel

DRUG

1.5% w/w diclofenac sodium topical solution

1.5% w/w diclofenac sodium topical solution

DRUG

75 mg diclofenac sodium delayed release tablet

75 mg diclofenac sodium delayed release tablet

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Maria J Gutierrez, MD · Comprehensive Phase One ®

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202799 on ClinicalTrials.gov