NCT07487740已完成1 期
A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Relative Bioavailability of NAL ER
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
排除标准
- •Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- •Positive urine drug or alcohol results at Screening or check in (Day -1).
- •Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
- •History of prolonged QT syndrome or a corrected QT (QTc) interval.
- •Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.
- •Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
研究组 & 干预措施
Cohort 2: NAL ER Dose B
Experimental
Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.
干预措施: NAL ER (Drug)
Cohort 1: NAL ER Dose A
Experimental
Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.
干预措施: NAL ER (Drug)
结局指标
主要结局
Relative Bioavailability of NAL ER
时间窗: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
次要结局
- Maximum Plasma Concentration (Cmax) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Time to Reach Maximum Observed Concentration (Tmax) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Apparent Terminal Rate Constant (λz) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Apparent Terminal Half-Life (t1/2) of NAL ER(Predose and at multiple timepoints postdose (from Day 1 to Day 8))
- Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Day 18)
研究者
研究点 (2)
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