NCT00513253撤回1 期
Relative Bioavailability of Four Alternative Oral Formulations Versus the Current Tablet Formulation of Lapatinib
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Plasma levels for lapatinib will be done at:
研究概览
简要总结
This study is designed to estimate the relative bioavailability of alternative lapatinib oral formulations compared to the current tablet formulation.
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
- •The subject is healthy as defined per protocol.
- •The subject is male or female.
- •A female is eligible to enter and participate in this study if she is of:
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- •Has had a documented (medical report verification) hysterectomy or double oophorectomy or
- •Is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or
- •Is post-menopausal (defined as females older than 45 years of age with 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels higher than 40 mIU/ml)
- •Childbearing potential, has a negative serum pregnancy test at Screening, and agrees to one of the following :
- •Complete abstinence from sexual intercourse from two weeks prior to administration of the study drug and throughout the study, and through the follow-up visit which will occur within 10 to 14 days after completion of the last treatment.
- •Vasectomized partner
- •Intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- •Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
- •Hormonal contraceptive plus male condom.
- •Age: 18 to 60 years inclusive.
- •BMI within the range 19 to 31.0 kg/m
- •Able to swallow and retain oral medication.
- •The subject is willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- •The subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
- •A signed and dated written informed consent is obtained from the subject or the subject's legally acceptable representative prior to screening.
排除标准
- •As a result of the medical interview, physical examination or screening investigations, the Principal Investigator considers the subject unfit for the study.
- •The subject meets ECG-related exclusion criteria listed in the protocol or has serum magnesium or potassium below the normal range at screening.
- •The subject has a history of drug or other allergy, which, in the opinion of the Principal Investigator, contraindicates participation.
- •The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, including but not limited to Tarceva (erlotinib) or Iressa (gefitinib).
- •The subject has a history of sensitivity to heparin or heparin-induced thrombocytopenia (applicable if heparin is used during pharmacokinetic sampling).
- •The subject participated in a study with a new molecular entity or any other trial during the previous 30 days.
- •The subject donated blood in excess of 500 mL within 56 days prior to dosing or intends to donate in the month after completing the study.
- •Use of prescription or non-prescription drugs (including vitamins and herbal supplements) within two weeks prior to dosing or during the study, however, acetaminophen up to two grams per day is acceptable.
- •History of alcohol/drug abuse or dependence within 12 months of the study as per protocol.
- •The subject is a smoker or has smoked in the last four months.
- •The subject tested positive for hepatitis C antibody, hepatitis B surface antigen, or HIV antibody.
- •The subject has a positive urine test for drugs of abuse or is positive for alcohol use at pre-study screening.
- •Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final PK blood sample.
结局指标
主要结局
Plasma levels for lapatinib will be done at:
时间窗: Day 1, Day 2, Day 3 for each Treatment Period
次要结局
- Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation
- Medical History(at screening)
- Vital Signs, ECGs, & Lab tests(at screening, Day 1, and f/u)
- Physical Exam(at screening & follow-up (f/u))
- Continuous Adverse Event monitoring(throughout the study)
研究者
研究点 (2)
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