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Cysteamine (Cys) is the only treatment of cystinosis in pediatric patients. Cys is available as the hydrochloride (Cys-HCl), the bitartrate (Cys-Bitar) salts and as phosphocysteamine (Cys-Phos). It has been suggested that Cys-Bitar and Cys-Phos are better tolerated and may have a better bioavailability than Cys-HCl. This has, however, never been clearly demonstrated. We therefore conducted a double-blind, latin-square, 3-period cross-over bioequivalence study in 18 healthy male adult volunteers. Each subject received one single oral dose (15.55 mM of Cys base) of each Cys form as 11 capsules. Each study period was separated by a 3-day drug-free interval. Plasma concentrations of Cys were determined with a sensitive and specific HPLC assay over a 12 hour period following each administration. Gastro-intestinal tolerance was assessed by counting vomiting episodes. The table gives the relative bioavailability (F) (mean +/- SD) and the 90% CI for the ratios of AUC 0 - ~ and observed C m a x for each drug-couple.No statistical difference was found between relative bioavailabilities, AUC, tmax and Cmax with each of the three forms of cysteamine tested. Cysteamine salts were bioequivalent (Confidence Intervals within 80-125%), except for their Cmax. The only significant adverse event was vomiting whose frequency was inversely correlated with body weight (rho=-0.76, p<0.001). The nature of the salt tested did not influence vomiting.In conclusion, Cys-HCl, Cys-Bitar and Cys-Rhos are fairly bioequivalent and their gastric tolerance is similar in healthy volunteers.
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