Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: May 2007

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• 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.
  • Time Frame: Several time points over 7 days
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Javelin Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Terri Lunsford, MD Principal Investigator PAREXEL International  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00474136

Study ID Number: DFC-PK-006

ClinicalTrials.gov Identifier: NCT00474136

Health Authority: United States: Food and Drug Administration