An Open-label, Randomized, Single Dose, Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap, 25mg in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.
详细描述
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively
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
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Over 20aged in healthy males
- •Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
- •The person who is determined to be the subject of the clinical laboratory test results such as hematology test, blood chemistry test, urine test, etc. set by the person in charge of the examination of the medical institution
- •BMI : 18-30
- •Those who have not donated blood within 2 weeks
- •Those without a history of gastrointestinal resection
- •Those who have no history of mental illness within the last 5 years
- •Agreement with written informed consent
- •Anyone who can follow and follow all scheduled admission and outpatient visits, dosing, clinical laboratory testing and subject compliance
- •If the partner is a woman of childbearing age who does not use the appropriate method of contraception (even if the man has undergone a vasectomy), while taking lenalidomide, during the interruption, for consenting to use condoms for 28 days after the last dose
- •In the vital sign measured in a sitting position, the systolic blood pressure ≤145 mmHg and ≥100 mmHg, the diastolic blood pressure ≤95 mmHg and ≥60 mmHg, the pulse rate> 40 and <100 times / minute
- •Electrocardiogram (ECG) of the 12-electrode, QTc ≤ 450 msec
- •Those who have agreed not to donate blood or plasma and semen for at least 28 days after taking this drug
- •If the contraceptive is withdrawn due to contraception or partner's pregnancy confirmation during testing. Those who agree to respond to follow-up within 6 months after pregnancy and after delivery
排除标准
- •Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
- •Those taking medication that could affect the test within 10 days before screening
- •The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
- •Those who have participated in the bioequivalence test or other clinical studies within 3 months prior to the administration of the test and administered the clinical trial drug
- •Persons with hypersensitivity to venous puncture
- •Screening Within the first 6 months, a person with a history of regular alcohol consumption as follows: 1 cup = 150 mL of wine or 360 mL of beer or 45 mL of distillate)
- •Patients with severe hepatic impairment
- •Patients who are hypersensitive to NSAIDs and other components of NSAID
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
- •Positive result of Serum test [RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)]
研究组 & 干预措施
SYP-1512
Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
干预措施: SYP-1512 (Drug)
Revlimid cap.
Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)
干预措施: Revlimid cap (Drug)
结局指标
主要结局
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)
时间窗: 0-24hours
Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)
时间窗: 0-24hours
Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)
次要结局
- Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)(0-inf)
- Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)(0-24hours)
- Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)(0-24hours)