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

NCT00509743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2009-02-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Intravenous diclofenac sodium (DIC075V)

High dose Diclofenac

DRUG

Intravenous diclofenac sodium (DIC075V)

Low Dose Diclofenac

Sponsors & Collaborators

  • Javelin Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • D. Ronald Goldwater, MD · Parexel

  • William Gerson, D.O. · Comprehensive Phase One

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509743 on ClinicalTrials.gov