NCT01919008已完成1 期
Phase I Study of FK949E - Comparison of Pharmacokinetics Between FK949E 50 mg Tablets and FK949E 150 mg Tablets in Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Maximum plasma concentration (Cmax) of unchanged quetiapine
研究概览
简要总结
This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.
详细描述
The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. The safety of FK949E in the population is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients considered to be able to understand and follow subject requirements, as judged by the investigator/sub-investigator.
- •Patients diagnosed with major depressive disorder according to the DSM-IV-TR by means of M.I.N.I.
- •BMI: 17.6 (inclusive) to 26.4 (exclusive).
排除标准
- •Current or past history of DSM-IV-TR Axis I disorder, except major depressive disorder, within the past 6 months before informed consent.
- •Concurrent DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status.
- •Current or past history of dependence of substances (other than caffeine and nicotine) or history of abuse or dependence of alcohol.
- •Unable to suspend treatment with inducers or inhibitors of the drug-metabolizing enzyme, cytochrome P450 3A4 (CYP3A4), for 14 days before the screening assessment and throughout the study.
- •Patients who could not use an appropriate contraception (condoms) during the study. Patients who were pregnant or lactating.
- •Patients (carriers) with documented or suspected renal failure, hepatic failure, serious cardiac disease,
- •hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS).
- •Patients receiving treatment for hypertension, or patients with concurrent hypertension or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator/sub-investigator.
- •Patients with concurrent hypotension (criterion for hypotension: a systolic blood pressure of less than 100 mmHg), or orthostatic hypotension
- •Patients with a mean QTcF interval of ≥450 ms on a 12-lead ECG at the screening assessment
- •Patients with the risk of torsades de pointe (e.g., those with a history of QT prolongation, those with familial long QT syndrome).
- •Concurrent malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug.
- •Concurrent malignancy or history of cured malignancy within 5 years
- •Current or past history of cerebrovascular disease or transient ischemic attack (TIA).
- •Received electroconvulsive therapy within 90 days before the screening assessment
研究组 & 干预措施
Group 1 (FK949E low dose tablet-first group)
Experimental
Days 1 and 2: One FK949E low dose tablet
Days 3 to 6: Three FK949E low dose tablets
Days 7 to 10: One FK949E high dose tablet
干预措施: FK949E (Drug)
Group 2 (FK949E high dose tablet-first group)
Experimental
Days 1 and 2: One FK949E low dose tablet
Days 3 to 6: One FK949E high dose tablet
Days 7 to 10: Three FK949E low dose tablets
干预措施: FK949E (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of unchanged quetiapine
时间窗: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
AUC24h (area under the curve for 24hr) of unchanged quetiapine
时间窗: For 24 hours after dosing
Frequent blood sampling on Day 6 and Day 10
次要结局
- Trough value of plasma concentration of unchanged quetiapine(For 24 hours after dosing)
- t1/2 of plasma concentration of unchanged quetiapine(For 24 hours after dosing)
- Maximum plasma concentration (Cmax) of quetiapine metabolites(For 24 hours after dosing)
- AUC (area under the curve) of quetiapine metabolites(For 24 hours after dosing)
- trough value of plasma concentration of quetiapine metabolites(For 24 hours after dosing)
- tmax of plasma concentration of quetiapine metabolites(For 24 hours after dosing)
- t1/2 of plasma concentration of quetiapine metabolites(For 24 hours after dosing)
- Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam(Up to Day 11)
研究者
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