Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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
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
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.
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.
- Healthy volunteers between 18 and 55 years of age.
- 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
Locations and Contacts
PAREXEL International, Baltimore, Maryland 21225, United States
Starting date: March 2007
Ending date: May 2007
Last updated: December 27, 2007