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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00509743
First received: July 27, 2007
Last updated: February 11, 2009
Last verified: February 2009
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014