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

December 27, 2007 updated by: Javelin Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

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
    • 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

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg
DIC075V 18.75 mg
Experimental: 2
Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg
DIC075V 37.5 mg
Active Comparator: 3
Drug: Oral diclofenac potassium 50 mg
Oral diclofenac potassium 50 mg
Other Names:
  • Cataflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Several time points over 7 days

Collaborators and Investigators

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

Sponsor

Javelin Pharmaceuticals

Investigators

  • Principal Investigator: Terri Lunsford, MD, Parexel

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

March 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2008

Last Update Submitted That Met QC Criteria

December 27, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFC-PK-006

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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