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Completed

NCT Number: NCT00474136

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL International

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous diclofenac sodium (DIC075V) 18.75 mg

Drug

DIC075V 18.75 mg

Intravenous diclofenac sodium (DIC075V) 37.5 mg

Drug

DIC075V 37.5 mg

Oral diclofenac potassium 50 mg

Drug

Oral diclofenac potassium 50 mg

Other names: Cataflam

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.

    Time frame: Several time points over 7 days

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 16, 2007
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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