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

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00474136

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg Drug: Oral diclofenac potassium 50 mg	Phase I

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Potassium chloride

U.S. FDA Resources

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

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	March 2007
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg DIC075V 18.75 mg
2: Experimental	Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg DIC075V 37.5 mg
3: Active Comparator	Drug: Oral diclofenac potassium 50 mg Oral diclofenac potassium 50 mg

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474136

Locations

United States, Maryland
PAREXEL International
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Principal Investigator:

Terri Lunsford, MD

PAREXEL International

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals ( Amy Cohen )
Study ID Numbers:	DFC-PK-006
Study First Received:	May 14, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00474136 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Healthy
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009