drugset / Trial / NCT00474136

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

NCT00474136

Phase 1 Completed 36 enrolled Javelin Pharmaceuticals
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Timeline

Start
2007-03
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 18.75 mg Intravenous
Comparator Diclofenac Other / unclassified 37.5 mg Intravenous
Comparator Diclofenac Other / unclassified 50 mg Oral

Indications

No indication recorded.