1. A fully replicated crossover bioequivalence study of mycophenolate mofetil capsules in Chinese healthy male subjects under fasting and fed conditions
Gexin SHI ; Jiguo ZHANG ; Gexin SHI ; Kun HE ; Qing WEN ; Jiguo ZHANG ; Rui CHONG ; Rong ZHANG ; Rui CHONG ; Rong ZHANG ; Haitang WU ; Yu ZHOU ; Zhongjun DUN
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(11):1255-1263
AIM: To evaluate the bioequivalence of the test and reference formulations of mycophenolate mofetil capsule in Chinese healthy male subjects under fasting and fed conditions. METHODS: This was a 2-treatment, 2-sequence, 4-period, fully replicated crossover study that included 80 Chinese healthy male subjects (40 subjects in the fasting group and 40 subjects in the fed group, respectively). Subjects were assigned to receive a single oral administration of the test or reference formulation at a dose of 0.25 g in each period. The plasma concentration of mycophenolate mofetil (MMF) and metabolite mycophenolic acid (MPA) were analyhed by LC-MS/MS. The major pharmacokinetic parameters of MMF and MPA were calculated using non-compartmental analysis by WinNonlin 8.0. The statistical analysis was performed by SAS 9.4. Average bioequivalence (ABE) analysis was applied where it has been demonstrated that the within-subject standard deviation of the reference formulation (S
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