Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00474136
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diclofenac
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
Narcotherapy
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, Dietary
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Sodium Isotopes
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.
Sodium Channels
Cell membrane glycoproteins selective for sodium ions. Fast sodium current is associated with the action potential in neural membranes.
Clinical Trials
The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V)...
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pa...
Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the locat...
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the locati...
PubMed Articles
The present study was undertaken to compare the bioavailability and pharmacokinetic parameters of diclofenac sodium and diclofenac potassium in normal and experimentally induced diabetic state in 24 r...
Study design:Laboratory investigation in rats submitted to experimental spinal cord injury (SCI).Objective:To determine the effect of acute SCI on the pharmacokinetics of diclofenac, a marker drug of...
Synthesis, characterization, and biological evaluation of novel diclofenac prodrugs.
Diclofenac ester pro drugs (4, 5, 6) were synthesized and evaluated in vitro and in vivo for their potential use for oral delivery, with the aim of obtaining enzymatically labile and less ulceration d...
Osteoarthritis (OA) is a chronic degenerative joint disease that is debilitating for many individuals. While oral nonsteroidal anti-inflammatory drugs (NSAIDs) remain a common and effective treatment...
Conventional dosage form is nowadays mostly replaced by sustained release formulation in order to increase drug efficacy and patient compliance. The sustained release properties of the PVP K90 alone a...
