Journal of Bioequivalence & Bioavailability

Xiaogao Zhang

Publications

• Research Article
  Bioequivalence Study of Two 30 Mg Tolvaptan Tablets Formulations in Healthy Chinese under Fed Condition
  Author(s): Xiaogao Zhang and Shengjun ZhangXiaogao Zhang and Shengjun Zhang
  
  Objective: The purpose of this study was to compare the bioavailability between the two 30 mg tolvaptan tablets formulations and to evaluate the bioequivalence of Reference and Test formulations of tolvaptan tablets 30 mg in healthy adult male and female subjects under fed condition. Method: 50 healthy Chinese male and female subjects were enrolled in a single-center, randomized, open-label, single-dose, two-treatment, two-sequence, two-period, crossover study. The plasma of tolvaptan were determined by a validated LC- MS/MS method. The bioequivalence of Test and Reference will be determined based on AUC0-t, AUC0‑inf and Cmax of tolvaptan in plasma. Results: All the 50 subjects completed the study and the main pharmacokinetic parameters for test and reference preparations were as follows: Cmax were 308.8 ± 108.8 and 339.9 ± 114.3 ng/mL, t.. View More»
  DOI: 10.4172/jbb.1000201

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