NCT00474136

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

Open-Label, Randomized, Single Center Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses) Versus Oral Diclofenac Potassium in Healthy Adult Volunteers Following Single- and Multiple-Dose Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Intravenous diclofenac sodium (DIC075V) 18.75 mg	DIC075V 18.75 mg
DRUG	Intravenous diclofenac sodium (DIC075V) 37.5 mg	DIC075V 37.5 mg
DRUG	Oral diclofenac potassium 50 mg	Oral diclofenac potassium 50 mg

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2007-05-16
• Last updated: 2008-01-04

Locations

1 site across 1 country: United States