A Single Centre, Two Period Crossover Study to Assess the Bioequivalence of an Oral Azathioprine Suspension 10 mg/mL (Jayempi™) Versus Oral Azathioprine Tablet 50mg (Imurek®) in at Least 30 Healthy Adult Subjects 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
- 2
- 主要终点
- AUC0-t
研究概览
简要总结
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at least 30 healthy adult subjects under fasting conditions.
详细描述
This will be a single-dose, open-label, randomised, two-period crossover study with orally administered 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) on two separate occasions conducted under fasting conditions in healthy male and female subjects at a single study centre.
The study will comprise:
- Thiopurine methyltransferase (TPMT) testing;
- Screening period of maximum 28 days
- Two treatment periods (each of which will include a PK profile period of 12 hours) separated by a wash-out period of at least 3 calendar days (minimum number of days based on half-life of the analyte) and maximum of 14 calendar days between consecutive administrations of the IMP
- A post-study visit 7-10 days after the last dose of the last treatment period of the study.
Subjects will be randomly assigned to treatment sequence, prior to the first administration of IMP.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers.
- •No significant medical history or conditions that may interfere with the study.
- •Adequate contraception.
排除标准
- •Volunteers who may be likely to have the inherited mutated NUDT
- •Subjects with a deficient, low or intermediate TPMT enzyme activity.
- •Disease that may interfere with the safety of the participant or the study outcome measures.
- •Participants who want to procreate in the next 6 months.
研究组 & 干预措施
Imurek®,
Generic name : Azathioprine Trade name : Imurek® 50mg tablet Dosage form : Tablet containing 50 mg azathioprine Dose : 1 x Imurek 50mg Tablet per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Aspen Pharma Trading Limited, Dublin, Ireland Country of origin : Ireland
干预措施: Azathioprine 50Mg Tab (Drug)
Jayempi™
Generic name : Azathioprine
Trade name : (Jayempi™) 10 mg/ mL Oral solution Dosage form : Oral suspension containing 10 mg/mL Azathioprine Dose : 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Nova Laboratories Ltd. Country of origin : Leicester, UK
干预措施: Azathioprine 10mg/mL oral suspension (Drug)
结局指标
主要结局
AUC0-t
时间窗: 18 hours
Area under the curve time=0 hours to t hours
AUC0-∞
时间窗: 18 hours
Area under to curve from time=0 hours to infinity
Maximum Observed Plasma Concentration (Cmax)
时间窗: 18 hours
The maximum (peak) plasma concentration assesses the rate of drug absorption
次要结局
未报告次要终点