title: [Bioequivalence of Ubenimex Capsules in Healthy Volunteers].
abstract: OBJECTIVE
  To evaluate bioequivalence of two specifications of ubenimex capsules in comparison with the Japanese branded product (R).
  
  
  METHODS
  The study adopted a 3-way crossover design in twenty-four healthy male volunteers, whose plasma concentrations of ubenimex were determined by UPLC-MS/MS after administration a single oral dose of 30 mg of domestic ubenimex T1 (10 mg/capsule), T2 (30 mg/capsule) and branded ubenimex R (30 mg/capsule) sequentially. The bioequivalence was evaluated using WinNonlin6. 1 statistical analysis software.
  
  
  RESULTS
  One volunteer was excluded because of failure to follow medication instructions. The main pharmacokinetic parameters of ubenimex of T1, T2 and R were as follows: C(max) (2 646.73 ± 454.09) ng/mL, (2 675.91 ± 474.32) ng/mL and (2 432.79 ± 544.32) ng/mL, respectively; T(max) (0.68 ± 0.23) h, (0.76 ± 0.19) h and (0.77 ± 0.26) h, respectively; AUC(0-t) (3 925.23 ± 478.34)(ng x h)/mL, (3 804.62 ± 448.84)(ng x h)/mL and (3 789.30 ± 443.15)(ng x h)/mL, respectively; AUC(0-∞)(3 938.31 ± 479.54)(ng x h)/mL, (3 817.26 ± 450.90) (ng x h)/mL and (3 800.90 ± 444.77) (ng x h)/mL, respectively; CL/F (7.72 ± 0.92) L/h, (7.97 ± 0.98) L/h and (7.99 ± 0.90) L/h, respectively; Vd (26.08 ± 9.20 )L, (25.65 ± 10.22) L and (26.03 ± 10.05) L, respectively. The relative bioavailability F(0-t) and F(0-∞) of T1 and T2 against the branded preparation R were (103.90 ± 9.19)% and (100.77± 9.36)%, and (103.93 ± 9.20)% and (100.79 ± 9.33)%, respectively.
  
  
  CONCLUSIONS
  Both ubenimex capsules T1 and T2 are bioequivalent to the Japanese branded products.
authors.forename: Jing
authors.initials: J
authors.lastname: Zheng
authors.forename: Jin
authors.initials: J
authors.lastname: Xiang
authors.forename: Jia
authors.initials: J
authors.lastname: Miao
authors.forename: Qin
authors.initials: Q
authors.lastname: Yu
authors.forename: Chao
authors.initials: C
authors.lastname: Hu
authors.forename: Yong-ping
authors.initials: YP
authors.lastname: Qin
authors.forename: Shi-qing
authors.initials: SQ
authors.lastname: Shu
authors.forename: Feng
authors.initials: F
authors.lastname: Nan
authors.forename: Ying
authors.initials: Y
authors.lastname: Wang
authors.forename: Xiao-hong
authors.initials: XH
authors.lastname: Zhu
mesh_terms: D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D064368:Healthy Volunteers; D006801:Humans; D007930:Leucine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood; D008297:Male; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency
chemical_list: D002214:Capsules; D007930:Leucine; C012211:ubenimex