A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bioequivalence of a New Tapentadol Extended-Release (TRF) 250-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 250-mg Tablet Under Fasted Conditions in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of tapentadol
研究概览
简要总结
The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.
详细描述
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study of a single dose of 250-mg tapentadol. All participants will receive in randomized order the TRF tablet and PR2 tablet, both as a single dose of 250 mg tapentadol. Approximately 64 participants will be enrolled in the study. The study consists of 3 phases: a screening phase (within 2 to 21 days before the first study drug administration on Day 1 of Period 1), an open-label treatment phase consisting of 2 single-dose treatment periods. Treatment administrations will be separated by a washout period of 7 to 14 days. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period: Treatment A: tapentadol ER 250-mg TRF tablet, administered as a single oral dose under fasted condition and Treatment B: tapentadol ER 250-mg PR2 tablet, administered as a single oral dose under fasted condition. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The duration of participation in the study for an individual participant will be up to 5.5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol
- •Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters performed within 21 days before study drug administration
- •Women must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period
- •Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- •Body mass index (BMI) (weight [kg]/height [m2]) between 20 and 28 kg/m2, inclusive, and body weight not less than 50 kg
排除标准
- •History of seizure disorder or epilepsy or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms
- •History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection
- •History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (eg, naloxone), benzodiazepines (eg, diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin
- •Women who plan to become pregnant during the study, or who are breast-feeding
- •Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
研究组 & 干预措施
Treatment A
Tapentadol ER 250-mg tamper-resistant formulation (TRF) tablet will be administered as a single oral dose under fasted condition.
干预措施: Tapentadol ER 250-mg TRF tablet (Drug)
Treatment B
Tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet will be administered as a single oral dose under fasted condition.
干预措施: Tapentadol ER 250-mg PR2 tablet (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of tapentadol
时间窗: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Cmax is defined as maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of tapentadol
时间窗: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of tapentadol
时间窗: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tapentadol
时间窗: Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Up to 5.5 weeks)