NCT00474136

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

2 months

First QC Date

May 14, 2007

Last Update Submit

December 27, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Several time points over 7 days

Study Arms (3)

1

EXPERIMENTAL
Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg

2

EXPERIMENTAL
Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg

3

ACTIVE COMPARATOR
Drug: Oral diclofenac potassium 50 mg

Interventions

Intravenous diclofenac sodium (DIC075V) 18.75 mgDRUG

DIC075V 18.75 mg

1
Intravenous diclofenac sodium (DIC075V) 37.5 mgDRUG

DIC075V 37.5 mg

2
Oral diclofenac potassium 50 mgDRUG

Oral diclofenac potassium 50 mg

Also known as: Cataflam
3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between 18 and 55 years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL International

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Terri Lunsford, MD

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 4, 2008

Record last verified: 2007-12

Locations

US(1)