Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects

  title={Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects},
  author={Lei Sheng and Wei Cao and Ping-ping Lin and Weili Chen and Hongrong Xu and Chunjiu Zhong and Fei Yuan and Hanjing Chen and Hui Li and Cuie Liu and Mengjie Yang and Xuening Li},
  journal={Drug Design, Development and Therapy},
  pages={1101 - 1110}
Purpose Safety, tolerability and pharmacokinetics of single and multiple ascending doses (SADs/MADs) of benfotiamine were assessed after oral administration in two randomized, double-blind, placebo-controlled, phase I trials. Methods Healthy subjects were sequentially enrolled into one of five SAD (150–1200 mg) or three MAD (150, 300 or 600 mg) cohorts. In SAD study, each cohort of 12 subjects (n = 10, active; n = 2, placebo) were administrated once-daily doses. In MAD study, each cohort of 16… Expand
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