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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg; Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg; Drug: Oral diclofenac potassium 50 mg

• Registration Number: NCT00474136
• Lead Sponsor: Javelin Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-16
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-27
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy volunteers between 18 and 55 years of age.

Exclusion Criteria

• Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
• Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs.
• History of previous and/or present peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or for HIV antibodies, or history of asthma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Intravenous diclofenac sodium (DIC075V) 18.75 mg	-
2	Intravenous diclofenac sodium (DIC075V) 37.5 mg	-
3	Oral diclofenac potassium 50 mg	-

Primary Outcome Measures

Name	Time	Method
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.	Several time points over 7 days

Trial Locations

Locations (1)

PAREXEL International; 🇺🇸 Baltimore, Maryland, United States