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

February 11, 2009 updated by: Javelin Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

89

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Low dose Diclofenac
Drug: Intravenous diclofenac sodium (DIC075V)
High dose Diclofenac
Drug: Intravenous diclofenac sodium (DIC075V)
Low Dose Diclofenac
Experimental: B
High dose Diclofenac
Drug: Intravenous diclofenac sodium (DIC075V)
High dose Diclofenac
Drug: Intravenous diclofenac sodium (DIC075V)
Low Dose Diclofenac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javelin Pharmaceuticals

Investigators

  • Principal Investigator: D. Ronald Goldwater, MD, Parexel
  • Principal Investigator: William Gerson, D.O., Comprehensive Phase One

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (Estimate)

July 31, 2007

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFC-PK-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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