Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

Key facts

Study ID

NCT00509743

Run by

Javelin Pharmaceuticals

People needed

89

Starts

2007-09-01

Expected to finish

2008-03-01

Last updated by the study team

2009-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult volunteers over age 18

You may not qualify if…

• Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation
• History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies

Where it is running

• Comprehensive Phase One — Miramar, Florida, United States
• PAREXEL International — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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