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...
Date First Received: July 27, 2007
Last Updated: February 5, 2008
Verified by: Javelin Pharmaceuticals, February 2008
Clinical Trial Phase: Phase 1 | Start Date: September 2007
Overall Status: Recruiting
Estimated Enrollment: 89
Brief Summary
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”
Condition Keyword(s):
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 Type: Interventional
Study Design: Other, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Detailed Clinical Trial 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.
Outcome Measures for this Clinical Trial
Primary:
- 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. 24 hours No
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Javelin Pharmaceuticals
Comprehensive Phase One
Miramar Florida 33025 United States
PAREXEL International
Baltimore Maryland 21225 United States
Overall Clinical Trial Officials and Contacts
D. Ronald Goldwater, MD Principal Investigator PAREXEL International
Overall Contact: Parexel Recruiting 877-617-8839 study.baltimore@parexel.com
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509743
Study ID Number: DFC-PK-008
ClinicalTrials.gov Identifier: NCT00509743
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
