An open-label, multiple-dose, crossover study to investigate the pharmacokinetic interaction and safety in combination with donepezil and herbal medicines in healthy adults

Yonsei University Health System, Severance Hospital0 个研究点目标入组 36 人开始时间: 待定最近更新: 2022年9月20日

试验速览

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•1) Those who have a history of gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendicectomy or hernia surgery) that may affect drug absorption
•2) Those who have a history of significant drug hypersensitivity to the components of research drugs (donepezil hydrochloride, piperidine derivatives, gamisoyosan, Banhasasimtang, Ojeoksan, Bojungikgitang, etc.)
•3) Those who are judged unsuitable for research subjects in a screening test conducted within 28 days before the first administration of the research drug
•4) Those who have consumed grapefruit-containing food within 7 days prior to the first administration of the research drug or cannot prohibit intake during the study period
•5) In the case of administration of prescription drugs or herbal medicines within 14 days before the first administration of research drugs, or over-the-counter medicines including health food and vitamin preparations within 7 days, the administered drug may affect the study If the researcher determines that it may affect
•6) Those who have taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates (including CYP3A4 inhibitors and inducers, and CYP2D6 inducers) within 30 days before the first administration of the research drug

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