Bioequivalence study,
Conditions
Interventions
Aricept® Evess 10 mg orodispersible tablet,
Reg. No. 1B 6/52 (N).,Generic donepezil hydrochloride 10 mg orodispersible tablet.
Active Comparator Drug,Active Comparator Drug
Donepezil hydrochloride 10 mg orodispersible tablet (Reference product),Donepezil hydrochloride 10 mg orodispersible tablet (Test product)
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Healthy Thai male/female subjects between the ages of 18 to 55 years. 2 Body mass index between 18 to 25 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 admission in Period 1. Injectable contraceptives e.g. Depo-Provera® must be discontinued at least 6 months. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission 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 admission in Period 1 until 7 days after the end of study. 7 Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1 History of allergic reaction or hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any of the components of the product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal e.g. peptic ulcer, hematological, endocrine e.g. thyroid, pulmonary or respiratory e.g. asthma, obstructive pulmonary disease, cardiovascular e.g. sick sinus syndrome, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3 History or evidence of syncopes or seizure 4 History or evidence of abnormal genitourinary conditions such as bladder outflow obstruction 5 History of sensitivity to heparin or heparin-induced thrombocytopenia 6 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 7 History of dehydration from diarrhea, vomiting, excess sweating or any other reason within 24 hours prior to admission or prior to dosing 8 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 9 Have pulse rate less than 60 or more than 100 beats per minute at screening or on the day of admission. 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. 10 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 should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility. 11 Investigation with blood sample shows positive test for HBsAg 12 Abnormal liver function,  1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 13 Creatine kinase levels > 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test 14 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 15 History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 16 History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 17 Consume or drink juice of grapefruit or orange or its supplement/ containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 18 Use of prescription or nonprescription drugs e.g. paracetamol, erythromycin, ketoconazole, loratadine, herbal medications or supplements e.g. St. John's wort, iron, vitamins or dietary supplements within 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Donepezil plasma concentration 0,0.25,0.50,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,24,48,72 hrs post-dose Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Donepezil plasma concentration 0,0.25,0.50,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,24,48,72 hrs post-dose Tmax, t1/2 and lamda Z | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co. Ltd.
Outcome results
None listed