title: Pharmacokinetics and comparative bioavailability of allopurinol formulations in healthy subjects.
abstract: Allopurinol is the most commonly used urate-lowering therapy in gout. This study was undertaken to evaluate the pharmacokinetics and relative bioavailability of two brands of allopurinol tablets. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, Two Way, Cross-Over Study with a washout period of 1 week. Under fasting conditions, 24 healthy male volunteers were randomly allocated to receive a single oral dose (200 mg) of either test and reference formulations. Plasma samples were obtained over a 6-hour interval and analyzed for allopurinol by reversed phase liquid chromatography with ultraviolet detection. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUCt-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two allopurinol formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 200-mg allopurinol and both formulations were well tolerated.
authors.affiliation: Faculty of Pharmacy, Department of Pharmaceutics, Damanhour University, Damanhour, Egypt.
authors.forename: Sally A
authors.initials: SA
authors.lastname: Helmy
authors.affiliation: Faculty of Pharmacy, Department of Industrial Pharmacy, Damanhour University, Damanhour, Egypt.
authors.forename: Heba M
authors.initials: HM
authors.lastname: El-Bedaiwy
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000493:Allopurinol / Q000008:administration & dosage* / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004339:Drug Compounding; D016903:Drug Monitoring / Q000379:methods; D004534:Egypt; D006074:Gout Suppressants / Q000008:administration & dosage* / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D006074:Gout Suppressants; D013607:Tablets; D000493:Allopurinol
keywords: HPLC; allopurinol; bioavailability; pharmacokinetics