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

Condition(s) targeted: Healthy

Intervention: Intravenous diclofenac sodium (DIC075V) 18.75 mg (Drug); Intravenous diclofenac sodium (DIC075V) 37.5 mg (Drug); Oral diclofenac potassium 50 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Javelin Pharmaceuticals

Official(s) and/or principal investigator(s):
Terri Lunsford, MD, Principal Investigator, Affiliation: PAREXEL International

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.

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

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

Primary outcome: 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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

PAREXEL International, Baltimore, Maryland 21225, United States

Starting date: March 2007
Ending date: May 2007
Last updated: December 27, 2007