A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of XARTEMIS® XR (7.5 Oxycodone Hydrochloride/325 mg Acetaminophen) in Postsurgical Adolescent Subjects (Ages 12 to 17) With Moderate to Severe Acute Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Time to Reach Steady State
研究概览
简要总结
Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of XARTEMIS XR in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XARTEMIS XR
All participants received XARTEMIS XR
干预措施: XARTEMIS XR (Drug)
结局指标
主要结局
Time to Reach Steady State
时间窗: within 60 hours
The time to reach steady state in participants who received all 5 doses
Area Under the Concentration-time Curve (AUC) From Time Zero (AUC0) to the Time of the Last Quantifiable Plasma Sample (AUClast)
时间窗: within approximately 12 hours (12.08 hours)
Elimination constant estimates required for the calculation of the planned AUC0-12 hours were not available. AUClast therefore provided the best available measure of exposure, effectively representing AUC0-12 hours for both moieties. While considered the best available measure, it also remains inaccurate because of the extended-release formulation and the lack of data beyond the 12.08-hour time point.
Maximum Observed Plasma Concentration (Cmax)
时间窗: within approximately 12 hours (12.08 hours)
The highest concentration of study drug within 12 hours.
Apparent Plasma Terminal Drug Elimination Half-life (T1/2)
时间窗: within approximately 12 hours (12.08 hours)
PK parameters are determined after a single administration of study drug on Day 1. Plasma concentrations that are below the level of quantification (BLQ) are set to 0 before Tmax, with the exception that a BLQ value occurring between measurable concentrations is set to missing. BLQ values that occur after Tmax are set to missing.
Time of Maximum Observed Plasma Concentration (Tmax)
时间窗: within approximately 12 hours (12.08 hours)
The time at which the maximum plasma concentration (Cmax) is reached.
次要结局
未报告次要终点