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Bioequivalence and Evaluation Parameters Based on the Pharmacodynamics of Miglitol in Healthy Volunteers.
Yan, Juan; Li, Xiao-Min; Zhang, Yan-Xin; Xu, Su-Mei; Liu, Wan-Li; Guo, Jie; Hu, Xiao-Lei; Zou, Ting; Xu, Yu-Ying; Xu, Ping-Sheng.
Afiliación
  • Yan J; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Li XM; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Zhang YX; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Xu SM; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Liu WL; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Guo J; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Hu XL; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Zou T; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Xu YY; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
  • Xu PS; Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Clin Pharmacol Drug Dev ; 10(6): 582-587, 2021 06.
Article en En | MEDLINE | ID: mdl-33058553
The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single-dose, randomized, open-label, 3-period, 3-way crossover trial over a 7-day washout period. Forty-eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (Cmax ) and the area under the serum glucose concentration-time curve through 4 hours (AUC0-4h ) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of Cmax and AUC0-4h were 94.81%-101.07% and 98.82%-100.72%, respectively, which were all within the bioequivalence range of 80.00%-125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Glucemia / 1-Desoxinojirimicina / Hipoglucemiantes Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2021 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Glucemia / 1-Desoxinojirimicina / Hipoglucemiantes Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2021 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos