Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Intravenous diclofenac sodium (DIC075V)

• Registration Number: NCT00509743
• Lead Sponsor: Javelin Pharmaceuticals

Brief 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.

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 Timeline

• Study First Submitted: 2007-07-27
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Study Start: 2007-09
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Intravenous diclofenac sodium (DIC075V)	Low dose Diclofenac
B	Intravenous diclofenac sodium (DIC075V)	High dose Diclofenac

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Comprehensive Phase One; 🇺🇸 Miramar, Florida, United States

PAREXEL International; 🇺🇸 Baltimore, Maryland, United States