A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Donepezil Hydrochloride 10 mg Orodispersible Tablets and Reference Product (Aricept Evess 10 mg) in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Bioequivalence Study Healthy Thai VolunteersDonepezil Hydrochloride 10 mg Orodispersible TabletsBioequivalence StudyHealthy Thai Volunteers
- Registration Number
- TCTR20210121002
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 34
1 Healthy Thai male or female subjects between the ages of 18 to 55 years.
2 Body mass index between 18.0 to 30.0 kg/m2.
3 Normal laboratory values, including vital signs and physical examination, for all
parameters in clinical laboratory tests at screening.
Any abnormalities from the normal or reference range will be carefully
considered clinically relevant by the physician as individual cases, documented in
study files prior to enrolling the subject in this study.
4 Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5 Female subjects abstain from either hormonal methods of contraception (including
oral or transdermal contraceptives, injectable progesterone, progestin subdermal
implants, progesterone-releasing IUDs, postcoital contraceptive methods) or
hormone replacement therapy for at least 28 days prior to check-in in Period 1.
Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months
prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal
contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for
at least 14 days prior to check-in in Period 1 until 14 days after the end of study in
Period 2. Female subjects of non-childbearing potential must meet at least one of
the following criteria prior to check-in in Period 1:
Postmenopausal for at least 1 year or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
hysterectomy) at least 6 months
6 Male subjects who are willing or able to use effective contraceptive e.g. condom or
abstinence after check-in in Period 1 until 14 days after the end of study in Period 2.
7 Have voluntarily given written informed consents (signed and dated) by the subject
prior to participating in this study
1 History of allergic reaction or hypersensitivity to donepezil hydrochloride or to
piperidine derivatives or to any excipients used in the formulation.
2 History or evidence of clinically significant renal, hepatic, gastrointestinal,
hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes
mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g.
hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion),
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing) or any significant ongoing chronic medical
illness
3 Have high risk for coronavirus infection based on risk assessment questionnaire or
diagnosed as confirmed case of COVID-19
4 History or evidence of syncopes or seizure
5 History or evidence of abnormal genitourinary conditions such as bladder outflow
obstruction
6 History or evidence of severe hepatic impairment
7 History or evidence of asthma or obstructive pulmonary disease
8 Has lesion or condition if considered a significant risk factor for peptic ulcer or
gastrointestinal bleeding
9 History or evidence of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption
10 History of problems with swallowing tablet or capsule
11 History of sensitivity to heparin or heparin-induced thrombocytopenia
12 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
gastritis or duodenal or gastric ulceration other than appendectomy
13 History of vomiting or diarrhea within 24 hours prior to check-in in each period
14 History or evidence of drug addict or investigation with urine sample shows a
positive test for drug of abuse (morphine, marijuana or methamphetamine)
15 Have pulse rate less than 60 or more than 100 beats per minute at screening or on
the check-in day in each period. If abnormal pulse rate detects, the measurement
should be repeated two more times after take a rest for at least 5 minutes each. The
last measurement value should be used to determine the subject s eligibility.
16 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an
abnormality considered clinically significant at screening. If QTc exceeds 450 msec,
or QRS exceeds 120 msec, the ECG will be repeated two more times and the
average of the three QTc or QRS values will be used to determine the subject s
eligibility
17 Investigation with blood sample shows positive test for HBsAg
18 Abnormal liver function, greater than or equal to 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
19 History or evidence of habitual use of tobacco or nicotine containing products and
cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for
entire duration of the study
20 History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e.,
alcohol consumption of more than 14 standard drinks per week for men and 7 standard
drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL
of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.)
30 Subjects who are employees of International Bio Service Co. Ltd. or sponsor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma donepezil concentrations 0-72.00 hours post-dose Cmax and Truncated AUC0-72
- Secondary Outcome Measures
Name Time Method Plasma donepezil concentrations 0-72.00 hours post-dose Tmax , t1/2 and The terminal elimination rate constant