title: Bioequivalence evaluation of two brands of rivastigmine of different salt forms, an acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, in healthy Beagle dogs.
abstract: The bioequivalence of two brands of rivastigmine capsules, of different salt forms, was demonstrated in six healthy beagle dogs after a single oral dose in a randomized cross-over study. Reference (Rivastigmine hydrochloride, Sunve, CN) and test (Rivastigmine tartrate, Novartis, CH) products were administered to fasting beagles on two treatment days separated by a two-day washout period; blood samples were collected at specified time intervals, and the plasma was separated and analyzed for rivastigmine using a validated GC-MS method. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), C(max), T(max) and t1/2 were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the State Food and Drug Administration (SFDA) of China. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable ranges for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Sanwei's Rivastigmine hydrochloride was bioequivalent to Rivastigmine tartrate of Novartis, CH.
authors: Department of Pharmaceutical Analysis, School of Pharmacy, Fudan University, Shanghai, PR China.
authors: Cidan
authors: C
authors: Shen
authors: Bei
authors: B
authors: Yang
authors: Tao
authors: T
authors: Zhou
authors: Gengli
authors: G
authors: Duan
authors: Yingjia
authors: Y
authors: Yu
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D000818:Animals; D019540:Area Under Curve; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D003627:Data Interpretation, Statistical; D004285:Dogs; D008401:Gas Chromatography-Mass Spectrometry; D006207:Half-Life; D008297:Male; D048448:Phenylcarbamates / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D000068836:Rivastigmine; D013810:Therapeutic Equivalency
chemical_list: D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine