Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults

Phase 1 Completed 16 enrolled Dr. Reddy's Laboratories Limited

RandomizedCrossoverOpen-labelOther

Summary

Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions

Timeline

Start: 2015-07-20
Primary completion: 2015-08-14
Completion: 2015-11-10

Publications

Results Pal A, Shenoy S, Gautam A, Munjal S, Niu J, Gopalakrishnan M, Gobburru J. Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers. Clin Drug Investig. 2017 Oct;37(10):937-946. doi: 10.1007/s40261-017-0548-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	120 mg	Oral
Subject	Celecoxib	Other / unclassified	180 mg	Oral
Subject	Celecoxib	Other / unclassified	240 mg	Oral
Subject	Celecoxib	Other / unclassified	400 mg	Oral

Indications

No indication recorded.