NCT00509743

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Intravenous diclofenac sodium (DIC075V)	High dose Diclofenac
DRUG	Intravenous diclofenac sodium (DIC075V)	Low Dose Diclofenac

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2007-07-31
• Last updated: 2009-02-12

Locations

2 sites across 1 country: United States