Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule) - Blood pharmacokinetic comparative study of Kampo preparations (Kakkonto) in japanese healthy male volunteers (kakkonto tablet and its extract granule)

ational Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics0 个研究点目标入组 20 人开始时间: 2017年12月1日最近更新: 2023年11月20日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The Japanese Journal of Pharmacognosy 74(2), 89-97 (2020). Our results suggest that the marker compounds exhibiting similar in pharmacokinetic parameters following the administration of Kampo extract granules and the corresponding standard decoction could be applied as markers for the evaluation of bioequivalence between already-approved Kampo extract granules and novel Kampo products based on the same extract as that of granules.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 45years-old（—）
性别: Male

入选标准

未提供

排除标准

•1. Subjects of less than 50 kilograms of body weight 2. Subjects with a history of allergic reactions to drugs and food(s) 3. Subjects who have participated in another clinical study within the past 16 weeks 4. Subjects who have had their blood drawn or who have donated 400 mL of blood within 12 weeks of study drug administration 5. Subjects with a history of a significant hepatic or respiratory disease 6. Subjects with a history of gastrointestinal disease (peptic ulcer, esophageal reflux) etc. except appendicitis 7. Subject with a history of digestive treat resection (except for appendicitis) 8. Subjects who are not able to stop smoking or drinking from the hospitalization day until completion of each treatment phase of the study 9. Subjects who are not able to stop taking medications and supplements during this trial 10. Subject who are judged inappropriate by the principal (or sub) doctor because the results of the screening test or 1st hospitalization day's test have deviated from the reference range 12. Subjects who are judged as ineligible to participate in the study for other reasons by the principal (or sub) doctor

研究者

发起方

ational Institute of Health Sciences Division of Pharmacognosy, Phytochemistry and Narcotics

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