NCT03424928已完成1 期
A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects should read, sign and date an Informed Consent Form and be fully informed of possible adverse events prior to any study procedures.
- •Subjects should complete the trial according to the regulations.
- •Subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. Subjects must agree to avoid semen and blood donation until 3 months of last dose administration.
- •Healthy male volunteers of 18-50 years old.
- •Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg.
- •Medically healthy subjects with clinically normal Neutrophils and Platelets within 14 days.
- •No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities.
排除标准
- •Smokers (>3 cigarettes/day)
- •History of allergic reactions to pomalidomide or Thalidomide analogues. Any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- •Any history of thrombus or liver, kidney diseases.
- •History of Alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week)
- •Recent donation of plasma or significant loss of whole blood (>400 ml) within 3 months.
- •Subjects have difficulty to swallow or any clinical significant history of ongoing gastrointestinal problems which affect absorption of drugs.
- •Received a prescription medicine within 2 weeks prior to study dosing.
- •Received a non-prescription drugs, traditional Chinese medicine, health products within prior to study dosing.
- •Received a special food (dragon fruit, grapefruit or other tropical fruit) or strenuous exercise within 1 week prior to study dosing. Regular use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study administration.
- •Any anticipation in other trial within 3 months.
- •Abnormal laboratory tests judged clinically significant.
- •Positive test result for HBsAg, HBeAg, HBeAb, HBcAB, HCvAB, HIV antibody, Syphilis screening antibody.
- •Received a caffeine/Xanthine beverages or food within 48 h prior to study dosing.
- •Received an alcohol within 24 h prior to study dosing or positive test result for alcohol screening.
- •Positive test result for drugs of abuse.
- •Other reasons which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Pomalidomide 4 MG Oral Capsule
Experimental
per os,capsule,4mg,1 capsule per period
干预措施: Pomalidomide 4 MG Oral Capsule (Drug)
Pomalidomide 4 MG Oral Capsule-Pomalyst
Experimental
per os,capsule,4mg,1 capsule per period
干预措施: Pomalidomide 4 MG Oral Capsule-Pomalyst (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)
时间窗: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)
时间窗: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
90% CI of T/R within 80-125%
次要结局
未报告次要终点
研究者
研究点 (1)
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