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Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

NCT00474136 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-01-04

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Conditions

  • Healthy

Interventions

DRUG

Intravenous diclofenac sodium (DIC075V) 18.75 mg

DIC075V 18.75 mg

DRUG

Intravenous diclofenac sodium (DIC075V) 37.5 mg

DIC075V 37.5 mg

DRUG

Oral diclofenac potassium 50 mg

Oral diclofenac potassium 50 mg

Sponsors & Collaborators

  • Javelin Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Terri Lunsford, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-05-31
Completion
2007-05-31

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 NCT00474136 on ClinicalTrials.gov