Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Intravenous diclofenac sodium (DIC075V) (Drug); Intravenous diclofenac sodium (DIC075V) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s):
D. Ronald Goldwater, MD, Principal Investigator, Affiliation: PAREXEL International
William Gerson, D.O., Principal Investigator, Affiliation: Comprehensive Phase One
Overall contact:
Parexel Recruiting, Phone: 877-617-8839, Email: study.baltimore@parexel.com
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.
Clinical Details
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 design: Other, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Parexel Recruiting, Phone: 877-617-8839, Email: study.baltimore@parexel.com
Comprehensive Phase One, Miramar, Florida 33025, United States; Recruiting
Luis Solano, Phone: 949-266-1000, Email: lsolano@cnsmail.com
PAREXEL International, Baltimore, Maryland 21225, United States; Recruiting
Phone: 877-617-8839
Additional Information
Starting date: September 2007
Ending date: April 2008
Last updated: February 5, 2008
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