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The Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions
  • +8
  • yinjuan li,
  • Lu Qi,
  • ying Liu,
  • Rongxia Fan,
  • Yongrui Tu,
  • Yongqiang Sun,
  • Juxiang Wang,
  • Qi Qi,
  • Xiaohui Feng,
  • Da Zhou,
  • Xinghe Wang
yinjuan li
Capital Medical University Affiliated Beijing Shijitan Hospital
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Lu Qi
Capital Medical University Affiliated Beijing Shijitan Hospital
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ying Liu
Capital Medical University Affiliated Beijing Shijitan Hospital
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Rongxia Fan
Capital Medical University Affiliated Beijing Shijitan Hospital
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Yongrui Tu
2.Changzhou Siyao Pharmaceuticals Co.,Ltd
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Yongqiang Sun
2. Changzhou Siyao Pharmaceuticals Co.,Ltd
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Juxiang Wang
2. Changzhou Siyao Pharmaceuticals Co.,Ltd
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Qi Qi
2. Changzhou Siyao Pharmaceuticals Co
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Xiaohui Feng
2. Changzhou Siyao Pharmaceuticals Co
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Da Zhou
2.Changzhou Siyao Pharmaceuticals Co.
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Xinghe Wang
Capital Medical University Affiliated Beijing Shijitan Hospital
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Abstract

Objective This study aims to evaluate the bioequivalence of 2 formulations of rasagiline tablet (1mg) in Chinese healthy subjects. Methods An open, randomized, single-dose, double-cycle, two-sequence, self-crossover pharmacokinetic study in healthy Chinese subjects under fasting and high-fat postprandial conditions was performed. A total of 108 healthy subjects (36 in the fasting group and 72 in the postprandial group) were recruited. In each of the two study periods under both conditions, subjects received a single oral dose of 1 mg test or a reference rasagiline (1 mg each). There was a 3-day washout period. Blood samples were obtained up to 10 hours post-intake. Several pharmacokinetic parameters were estimated based on the concentrations of rasagiline measured in plasma by means of LC-MS/MS. Results The geometric mean ratio (90% CI) of the test drug versus reference drug for rasagiline was 94.16% to 105.35% for AUC0-t under fasting conditions and 99.88% to 107.07% under postprandial conditions. The AUC0-∞s were 93.55% to 105.01% and 99.59% to 107.05% under fasting and postprandial conditions, respectively. The Cmax values were 88.26% to 108.46% and 89.54% to 118.23% under two conditions, respectively. The 90% CIs for test/reference AUC ratio and Cmax ratio were within the acceptable range (0.80–1.25) for BE. There were no serious adverse events (AEs) encountered during this BE study. Conclusion Bioequivalence between the test and the reference products was established in both fasting and postprandial conditions. The two types of rasagiline showed good tolerability and a similar safety profile.