A Relative Bioavailability Study of 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Cmax of Donepezil.
研究概览
简要总结
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 20% for height and weight as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
- •Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- •If female and:
- •of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s); or
- •is postmenopausal for at least 1 year; or
- •is surgically sterile.
排除标准
- •Volunteers with a recent history of drug or alcohol addiction or abuse.
- •Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems(s) or psychiatric disease (as determined by the clinical investigators).
- •Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on reexamination are deemed to be clinically significant.
- •Volunteers demonstrating a reactive screen for Hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- •Volunteers demonstrating a positive drug abuse screen when screened for this study.
- •Female volunteers demonstrating a positive pregnancy screen.
- •Female volunteers who are currently breastfeeding.
- •Volunteers with a history of allergic response(s) to donepezil or related drugs.
- •Volunteers with a history of clinically significant allergies including drug allergies.
- •Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- •Volunteers who currently use tobacco products.
- •Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- •Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing.
- •Volunteers who have donated plasma within 14 days of Period I dosing.
- •Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- •Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
- •Female volunteers who report the use of oral contraceptives or injectable contraceptives.
研究组 & 干预措施
Investigational Test Product
Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg
干预措施: Donepezil Hydrochloride (Drug)
Reference Listed Drug
Aricept® Orally Disintegrating Tablets, 10 mg
干预措施: Aricept® (Drug)
结局指标
主要结局
Cmax of Donepezil.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Donepezil.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
次要结局
未报告次要终点