Pharmacokinetic interaction of donepezil and herbal medicines

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007588

Enrollment

Registered

2022-07-29

Start date

2022-09-12

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This study is conducted as an open-label, multiple-dose, and crossover design study for each part. Each part consists of three periods, with a break of at least 14 days between period 1 and per

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Donepezil Cmax,ss, AUCtau,ss	—

Secondary

Measure	Time frame
Donepezil AUCinf,ss, Tmax, t1/2	—

Countries

Korea, Republic of

Contacts

Public ContactChoonok Kim

Yonsei University Health System, Severance Hospital

delivery-kiki@hanmail.net+82-2-2228-0455

Outcome results