A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions
研究概览
简要总结
This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, non-smoker, ≥18 and ≤65 years of age, with Body Mass Index (BMI) >18.5 and <30.0 kg/m2
- •Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study
- •Capable of consent
排除标准
- •Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- •Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening
- •History of allergic reactions to cyclobenzaprine, any of the formulation components, or other related drugs
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration
- •Positive pregnancy test at screening
- •Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
- •History of significant alcohol or drug abuse within one year prior to screening
- •Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration
- •Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
- •Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing.
- •Abnormal hemoglobin and hematocrit levels at screening
- •Breast-feeding subject
- •Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure
研究组 & 干预措施
Treatment A
TNX-102 SL 2.8 mg, under fasting conditions
干预措施: TNX-102 SL (Drug)
Treatment B
TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions
干预措施: TNX-102 SL (Drug)
Treatment C
TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions
干预措施: TNX-102 SL (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions
时间窗: Day 1 to Day 6
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions
时间窗: Day 1 to Day 15
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions
时间窗: Day 1 to Day 6
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions
时间窗: Day 1 to Day 15
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
次要结局
未报告次要终点