Status and phase
Conditions
Treatments
About
This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.
Full description
A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Hypersensitivity to, or history of clinically significant hypersensitivity to donepezil hydrochloride, piperidine derivatives or any ingredients of piperidine derivatives, or other drugs (aspirin, antibiotics, etc.)
Hereditary disorders including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption
History of heart disease such as sinus node syndrome, intra-atrial conduction disturbance or atrioventricular junctional conduction disturbance
Ongoing administration of non-steroidal anti-inflammatory drugs or history of peptic ulcer
History of asthma or obstructive pulmonary disease
Extrapyramidal disorder
Psychotic disorders or drug addiction
Presence or prior history of a gastrointestinal disorder or prior history of gastrointestinal surgery or skin graft that may affect the absorption of the IP
Presence or prior history of clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematological and oncological, psychotic, or urinary disease
Clinically significant hypotension (systolic blood pressure < 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
Any of the following results from screening tests:
QTc > 450 ms or any clinically significant abnormal finding from an ECG result at screening
Continuous alcohol intake or inability to stop drinking during the study period
Continuous smoking or inability to stop smoking throughout the hospitalization during the study period
Participated in another clinical study or bioequivalence study within 6 months prior to the first administration of the IP
Donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration of the IP
Used any prescription drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs within 7 days prior to the first administration of the IP
Used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbitals, within 1 month prior to initiation of the study
Have been on a diet (especially grapefruit juice or its product) which may affect absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first administration of the IP
Do not agree to exclude the possibility of pregnancy by using medically acceptable methods of contraception from the first day of administration of the IP up to 7 days after the last day of administration of the IP
Unwillingness or inability to comply with the diet and lifestyle guidelines required for the study
Clinically significant abnormal laboratory results or considered ineligible for study participation by the investigator for any other reason
Women who are pregnant, have a positive serum/urine hCG test, or are breastfeeding
Primary purpose
Allocation
Interventional model
Masking
18 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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