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

NCT ID: NCT00474136

Last Updated: 2008-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Intravenous diclofenac sodium (DIC075V) 18.75 mg

Intervention Type DRUG

DIC075V 18.75 mg

2

Group Type EXPERIMENTAL

Intravenous diclofenac sodium (DIC075V) 37.5 mg

Intervention Type DRUG

DIC075V 37.5 mg

3

Group Type ACTIVE_COMPARATOR

Oral diclofenac potassium 50 mg

Intervention Type DRUG

Oral diclofenac potassium 50 mg

Interventions

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Intravenous diclofenac sodium (DIC075V) 18.75 mg

DIC075V 18.75 mg

Intervention Type DRUG

Intravenous diclofenac sodium (DIC075V) 37.5 mg

DIC075V 37.5 mg

Intervention Type DRUG

Oral diclofenac potassium 50 mg

Oral diclofenac potassium 50 mg

Intervention Type DRUG

Other Intervention Names

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Cataflam

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers between 18 and 55 years of age.

Exclusion Criteria

* Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
* Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs.
* History of previous and/or present peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or for HIV antibodies, or history of asthma.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Javelin Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Javelin Pharmaceuticals

Principal Investigators

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Terri Lunsford, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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PAREXEL International

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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DFC-PK-006

Identifier Type: -

Identifier Source: org_study_id

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