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Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium (DFC-PK-008)

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ClinicalTrials.gov Identifier: NCT00509743
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Intravenous diclofenac sodium (DIC075V) Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Primary Completion Date : February 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: William Gerson, D.O. Comprehensive Phase One
More Information

Responsible Party: Gabrielle Poirier, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00509743     History of Changes
Other Study ID Numbers: DFC-PK-008
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action