Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel

NCT01202799 ↗

Phase 1 Completed 30 enrolled Mallinckrodt

RandomizedCrossoverOpen-labelBasic science

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).

Timeline

Start: 2010-09
Primary completion: 2010-11
Completion: 2010-11

Publications

Holt RJ, Taiwo T, Kent JD. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers. Postgrad Med. 2015 Aug;127(6):581-90. doi: 10.1080/00325481.2015.1058689. Epub 2015 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	1.5 %	Topical
Subject	Diclofenac	Other / unclassified	2 %	Topical
Subject	Diclofenac	Other / unclassified	75 mg	Topical

Indications

No indication recorded.