A Phase 1, Randomized, Single Center, Open-Label, Multiple-Dose, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Bioavailability and Safety of PENNSAID Gel in Comparison With Sandoz 75 mg Diclofenac Sodium Delayed Release Tablet and PENNSAID (Diclofenac Sodium Topical Solution) in Healthy Volunteers

NCT01202799 Phase 1 COMPLETED

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).

Details

Lead sponsor	Mallinckrodt
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2010-09
Completion	2010-11

Conditions

• Pain

Interventions

• 2% w/w diclofenac sodium topical gel
• 1.5% w/w diclofenac sodium topical solution
• 75 mg diclofenac sodium delayed release tablet

Primary outcomes

• The rate and extent of exposure of diclofenac will be assessed. — During each of the 3 periods, blood samples will be obtained on Day 1 and Day 8 at pre-dose and 1, 2, 3, 4, 6, 8 and 12 hours post-dose; on Days 2-7 at pre-dose; and on Days 9, 13 and 15 at approximately 8 AM.
  Summary statistics including the mean, standard deviation, coefficient of variation, geometric mean and geometric %CV will be calculated for all PK parameters by treatment.

Countries

United States