A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Observed Analyte Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, urinalysis or breathing alcohol test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- •Have no history of psychiatric disorder within the 5 years prior to the screening
- •Have no history of gastrointestinal resection that may affect drug absorption
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
- •Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
- •History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- •Taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug
研究组 & 干预措施
Treatment Sequence 1: Reference Drug + Test Drug (RT)
Participants will receive 8 hour (H) extended-release (ER) acetaminophen tablet orally in period 1 (Reference) followed by newly formulated acetaminophen tablet orally in period 2 (Test). Each period will be separated by a washout period of at least 7 days.
干预措施: Acetaminophen (Drug)
Treatment Sequence 2: Test Drug + Reference Drug (TR)
Participants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8 hour ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Maximum Observed Analyte Concentration (Cmax)
时间窗: Up to 24 hours post-dose
Cmax is the maximum observed analyte concentration.
Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])
时间窗: Up to 24 hours post-dose
AUC (0-last) is the area under the concentration-time curve from time 0 to time of the last measurable concentration (non-below quantitation limit).
次要结局
- Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])(Up to 24 hours post-dose)
- Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (Extrapolated %AUCinfinity)(Up to 24 hours post-dose)
- Time to Last Measurable Plasma Concentration (T [last])(Up to 24 hours post-dose)
- Time to Reach the Maximum Observed Analyte Concentration (Tmax)(Up to 24 hours post-dose)
- Elimination Rate Constant (Lambda [z])(Up to 24 hours post-dose)
- Elimination Half-Life (t 1/2)(Up to 24 hours post-dose)
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to 41 days)