Bioequivalence of Lasmiditan Oral Disintegrating Tablet Compared to Current Immediate-Release Tablet Formulation to Support Treatment of Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
研究概览
简要总结
The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation.
- •Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).
排除标准
- •Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
- •Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
- •Have clinically significant abnormalities on ECG, as determined by investigator.
- •Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
- •Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
研究组 & 干预措施
100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)
Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
干预措施: Lasmiditan (Drug)
100 mg Lasmiditan OD With Water (Test)
Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
干预措施: Lasmiditan (Drug)
100 milligram (mg) Lasmiditan immediate release (IR) (Reference)
Participants received 100 mg lasmiditan as IR tablet formulation administered orally.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
PK: Cmax of Lasmiditan.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
PK: AUC\[0-inf\] of Lasmiditan.
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
PK: AUC\[0-tlast\] of Lasmiditan.
次要结局
未报告次要终点