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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00474136

Run by

Javelin Pharmaceuticals

People needed

36

Starts

2007-03-01

Expected to finish

2007-05-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers between 18 and 55 years of age.

You may not qualify if…

• 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.

Where it is running

• PAREXEL International — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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