title: Evaluation of bioequivalence of two formulations containing 100 milligrams of aceclofenac.
abstract: The bioequivalence of two oral formulations containing aceclofenac 100 mg was determined in 24 healthy Indian male volunteers. The study was designed as a single dose, fasting, two-period two-sequence crossover study with a washout period of 1 week. The content of aceclofenac in plasma was determined by a validated HPLC method with UV detection. The preparations were compared using the parameters area under the plasma concentration-time curve (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-infinity), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). No statistically significant difference was observed between the logarithmic transformed AUC0-infinity and Cmax values of the two preparations. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-t, AUC0-infinity, and Cmax were within the bioequivalence limit of 0.80-1.25.
authors.affiliation: Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
authors.forename: K V
authors.initials: KV
authors.lastname: Gowda
authors.forename: D S
authors.initials: DS
authors.lastname: Rajan
authors.forename: U
authors.initials: U
authors.lastname: Mandal
authors.forename: P S
authors.initials: PS
authors.lastname: Selvan
authors.forename: W D
authors.initials: WD
authors.lastname: Sam Solomon
authors.forename: A
authors.initials: A
authors.lastname: Bose
authors.forename: A K
authors.initials: AK
authors.lastname: Sarkar
authors.forename: T K
authors.initials: TK
authors.lastname: Pal
authors.forename: T K
authors.initials: TK
authors.lastname: Chattaraj
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004008:Diclofenac / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D004341:Drug Evaluation; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D013810:Therapeutic Equivalency
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D016568:Drugs, Generic; D004008:Diclofenac; C056498:aceclofenac