Title: Piroxicam immediate release formulations: A fasting randomized open‐label crossover bioequivalence study in healthy volunteers
Abstract: Abstract Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single‐center, randomized, single‐dose, laboratory‐blinded, 2‐period, 2‐sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144‐hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters C max , t max , AUC 0–t , AUC 0–∞ , V d /F, Cl/F, and t 1/2 were determined from plasma concentration–time profiles. The 90% confidence intervals for the ratio of log transformed values of C max , AUC 0–t , and AUC 0–∞ of the two treatments were within the acceptable range (0.8–1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20‐mg piroxicam and both formulations were well‐tolerated.
Publication Year: 2014
Publication Date: 2014-02-09
Language: en
Type: article
Indexed In: ['crossref', 'pubmed']
Access and Citation
Cited By Count: 4
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot