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.
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.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intravenous diclofenac sodium (DIC075V) 18.75 mg, Intravenous diclofenac sodium (DIC075V) 37.5 mg, Oral diclofenac potassium 50 mg
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00474136
- Information obtained from ClinicalTrials.gov on July 15, 2010
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.
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)...
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
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...
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...
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...
Diclofenac sodium, a widely detected pharmaceutical drug in wastewater samples, has been selected as a model pollutant for degradation using novel combined approach of hydrodynamic cavitation and hete...
Objective: To compare the three non-steroidal anti-inflammatory agents (NSAIDs) diclofenac potassium, etodolac and naproxen sodium in relation to pain, swelling and trismus following impacted third mo...
Nonsteroidal anti-inflammatory drugs (NSAIDs) are particularly used in patients with bone fractures, but there are limited studies on whether one NSAID is superior to another. In this study, we used h...
In the pharmaceutical industry, co-crystals are becoming increasingly valuable as crystalline solids that can offer altered/improved physical properties of an active pharmaceutical ingredient (API) wi...
In vitro analysis of drug release and antimicrobial activity of the coblended crosslinked polymeric fibre device (PFD) were investigated. The fibre loaded with ciprofloxacin and diclofenac sodium was...