Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Assessing Bioequivalence Of Zoloft ODT 50 Mg Under Fasting Condition With And Without Water To Jzoloft Tablet 50 Mg Under Fasting Condition With Water In Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese subjects between the ages of 20 and 55 years.
- •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
- •Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk per criteria.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
研究组 & 干预措施
JZoloft
Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
干预措施: JZoloft (Drug)
ODT without water
sertraline ODT 50 mg without water as a single oral dose under fasted conditions
干预措施: sertraline ODT (Drug)
ODT with water
sertraline ODT 50 mg with water as a single oral dose under fasted conditions
干预措施: sertraline ODT (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
时间窗: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions
时间窗: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
次要结局
- Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions(0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose)
- Terminal elimination rate constant (kel), half-life (t½) and mean residence time (MRT) of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions(0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose)
- Safety laboratory tests, vital signs, and adverse events (AEs)(From Periods 1 to 3)
- AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions(0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose)
- Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions(0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose)