Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium - Full Text View

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509743

Purpose

The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

Condition	Intervention	Phase
Healthy	Drug: Intravenous diclofenac sodium (DIC075V)	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	An Open-Label, Single-Dose Study to Assess the Effects of Age, Weight, and Body Composition on the Pharmacokinetic Profile, Safety, and Tolerability of Intravenous Diclofenac Sodium (DIC075V) in Adult Volunteers

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	89
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Low dose Diclofenac	Drug: Intravenous diclofenac sodium (DIC075V) Low Dose Diclofenac
Experimental: B High dose Diclofenac	Drug: Intravenous diclofenac sodium (DIC075V) High dose Diclofenac

Detailed Description:

This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult volunteers over age 18

Exclusion Criteria:

Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation
History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509743

Locations

United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025
United States, Maryland
PAREXEL International
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Principal Investigator:	D. Ronald Goldwater, MD	PAREXEL International
Principal Investigator:	William Gerson, D.O.	Comprehensive Phase One

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gabrielle Poirier, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509743 History of Changes
Other Study ID Numbers:	DFC-PK-008
Study First Received:	July 27, 2007
Last Updated:	February 11, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

Adult volunteers

Additional relevant MeSH terms:

Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012