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

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ClinicalTrials.gov Identifier: NCT00474136
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : January 4, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg Drug: Oral diclofenac potassium 50 mg Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized, Single Center Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses) Versus Oral Diclofenac Potassium in Healthy Adult Volunteers Following Single- and Multiple-Dose Administration
Study Start Date : March 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg
DIC075V 18.75 mg
Experimental: 2 Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg
DIC075V 37.5 mg
Active Comparator: 3 Drug: Oral diclofenac potassium 50 mg
Oral diclofenac potassium 50 mg
Other Name: Cataflam


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: Several time points over 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474136


Locations
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United States, Maryland
PAREXEL International
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
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Principal Investigator: Terri Lunsford, MD Parexel
More Information
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Responsible Party: Amy Cohen, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00474136    
Other Study ID Numbers: DFC-PK-006
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007
Additional relevant MeSH terms:
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Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action