A open-label, balanced, randomised, single-dose, two-treatment, three-period, three-sequence, oral bioequivalence study of asenapine sublingual tablets in a three-way crossover, partial replicate, reference scaled, comparison against the innovator asenapine sublingual tablets conducted under fasting conditions in healthy male and female volunteers

Zenith Technology Corporation Limited0 个研究点目标入组 36 人开始时间: 2013年6月12日最近更新: 2020年1月13日

适应症

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•Healthy males and Females
•Aged between 18 and 55
•Non-smoker
•BMI between 19 and 30
•Normal, healthy individuals as determined by medical history, physical examination, ECG, bood 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
•Histroy of abnormal heartbeats or frequent palpitations or who have a family history of long QTc syndrome
•History of orthostatic hypotension, fainting or dizziness, epilepsy or seizures, diabetes or neuroleptic malignant syndrome
•History of depression, or other mental illness and/or have received treatment with antipsychotic medication
•Pregnant or breast-feeding
•Sensitivity to asenapine, any antipsychotic medicines, with excipients of asenapine
•History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
•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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