MedPath

Pharmacokinetic interaction of donepezil and herbal medicines

Not Applicable
Conditions
Mental and behavioural disorders
Registration Number
KCT0007588
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
36
Inclusion Criteria

1) Healthy adult
2) Those with a body mass index of 18.5 kg/m2 or more and less than 28.0 kg/m2

Exclusion Criteria

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Donepezil Cmax,ss, AUCtau,ss
Secondary Outcome Measures
NameTimeMethod
Donepezil AUCinf,ss, Tmax, t1/2
© Copyright 2025. All Rights Reserved by MedPath