ACTRN12614000599673已完成1 期
A single dose, randomized, blinded, bioequivalence study of a test formulation of fingolimod capsule in a 2 way crossover comparison against the innovator fingolimod capsule conducted under fed conditions in healthy male and female volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy males and non-pregnant females
- •Aged between 18 and 45
- •Non-smoker
- •BMI between 18 and 25
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Able to provide written informed consent
排除标准
- •Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
- •Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
- •Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
- •History or family history of depression or other mental illness, epilepsy or seizures
- •Who have a history of bleeding disorders or blood clotting problems
- •Sensitivity to fingolimod any other similar class medicines, excipients of fingolimod
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Who have any eye problems or conditions especially inflammation of the eye
- •Who have had a clinical illness within 4 weeks prior to the start of the study
- •Who have received any vaccinations within 1 month prior to dosing
- •Who are lactose intolerant
- •Females who are breastfeeding or are planning to start a family within 60 days of dosing
- •Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
- •Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk.
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