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

Javelin Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg

Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg

Drug: Oral diclofenac potassium 50 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00474136

DFC-PK-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.