TCTR20210121002尚未招募1 期
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
International Bio Service Co., Ltd.0 个研究点目标入组 34 人开始时间: 2021年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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