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

06:14 EDT 16th April 2014 | BioPortfolio

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.

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

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Intravenous diclofenac sodium (DIC075V) 18.75 mg, Intravenous diclofenac sodium (DIC075V) 37.5 mg, Oral diclofenac potassium 50 mg

Location

PAREXEL International
Baltimore
Maryland
United States
21225

Status

Completed

Source

Javelin Pharmaceuticals

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

Intravenous injections of sodium amytal or sodium pentothal to induce a state in which the patient is more relaxed and communicative. Narcosuggestion, narcosynthesis, and narcoanalysis are therapeutic processes using these drug adjuncts.

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

Stable sodium atoms that have the same atomic number as the element sodium, but differ in atomic weight. Na-23 is a stable sodium isotope.

Cell membrane glycoproteins selective for sodium ions. Fast sodium current is associated with the action potential in neural membranes.

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