ISRCTN89596264已完成未知
Randomised, open-label, 2-way crossover bioequivalence study of donepezil 10mg orodispersible film versus donepezil 10mg orodispersible tablet in healthy subjects under fasting conditions
Applied Pharma Research [APR] (Switzerland)0 个研究点目标入组 40 人开始时间: 2012年3月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Male and female participants
- •2. Non-smokers
- •3. Aged between 18 and 55 years of age
- •4. BMI between 18.5 and < 30.0
- •5. Healthy as defined by:
- •5.1. The absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator.
- •5.2. The absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- •6. Females of childbearing potential who are sexually active must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after:
- •6.1. Intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration
- •6.2. Condom or diaphragm and spermicide starting at least 14 days prior to study drug administration
- •6.3. Hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study
- •6.4. Sterile male partner (vasectomized since at least 6 months)
- •7. Capable of consent
排除标准
- •1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening
- •2. Positive urine drug screen or urine cotinine test at screening
- •3. History of allergic reactions to donepezil, piperidine derivates, dimenhydrinate or derivatives, or other related drugs
- •4. Use of any drugs known to induce or inhibit CYP 2D6 or CYP 3A4 within 30 days prior to administration of the study medication
- •5. Positive pregnancy test at screening
- •6. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study
- •7. Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening
- •8. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol])
- •9. History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
- •10. Use of an investigational drug within 30 days (90 days for biologics) or participation in an investigational study within 30 days prior to dosing
- •11. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
- •11.1. Prescription medication within 14 days prior to the first dosing
- •11.2. Over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2g daily)
- •11.3. A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing
- •12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing
- •13. Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening
- •14. Breast-feeding subject
- •15. Presence of tongue piercing or braces at the time of dosing
- •16. Clinically significant abnormal laboratory values at screening. Note: Eosinophils, Neutrophils and Lymphocytes values must not go over 1.5 times the upper limit of normal.
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