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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Javelin Pharmaceuticals
• Treatments: Diclofenac

Criteria

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.