A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
研究概览
简要总结
This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), 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 component, 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 dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue
研究组 & 干预措施
Treatment A (TNX-102 SL)
2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days
干预措施: TNX-102 SL 5.6 mg (Drug)
Treatment B (AMRIX)
1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days
干预措施: Amrix 30 mg (Drug)
结局指标
主要结局
Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
时间窗: Day 1 to Day 27
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).
Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
时间窗: Day 1 to Day 27
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).
Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg
时间窗: Day 1 to Day 47
Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
时间窗: Day 1 to Day 47
TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.
次要结局
未报告次要终点