A single dose, randomized, blinded, two-period comparative bioequivalence study of a test formulation of fingolimod capsule against the innovator fingolimod capsule conducted under fasting conditions in healthy subjects

Zenith Technology Corporation Limited0 个研究点目标入组 24 人开始时间: 2015年10月7日最近更新: 2020年1月13日

试验速览

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•Healthy males and non-pregnant females
•Aged between 18 and 45
•Non-smoker
•BMI between 18 and 25 inclusive
•Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
•Able to provide written informed consent

•Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
•Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
•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
•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)
•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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