NCT00988624已完成1 期
A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit).
研究概览
简要总结
This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Subjects with any history of a previous seizure (including childhood febrile seizures) or convulsion or significant head trauma.
- •Subjects with hypersensitivity reactions to dimebon or other antihistamines.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Smokers who use greater than 5 cigarettes per day.
- •Use of proton pump inhibitors, antacids, and H2-blockers are prohibited for the duration of the study.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception.
研究组 & 干预措施
Period 1
Experimental
干预措施: Dimebon IR Tablet (Drug)
Period 2
Experimental
干预措施: Dimebon MR1 (Drug)
Period 3
Experimental
干预措施: Dimebon MR2 (Drug)
Period 4
Experimental
干预措施: Dimebon MR3 (Drug)
Period 5
Experimental
干预措施: Dimebon MR4 (Drug)
结局指标
主要结局
PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit).
时间窗: Day 1-3 of Period 1, 2, 3, 4, or 5
次要结局
- Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs)(Day 1-3 of Period 1, 2, 3, 4, or 5)
研究者
研究点 (1)
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