A single dose, randomized, open label, crossover comparative bioavailability study of beclomethasone dipropionate in healthy male and female volunteers under fasting conditions with and without concurrent oral charcoal blockade.

Zenith Technology Corporation Limited0 个研究点目标入组 24 人开始时间: 2014年9月15日最近更新: 2020年1月13日

试验速览

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•Healthy male and non-pregnant females
•Aged between 18 and 45
•Non-smoker
•BMI between 18.5 and 30 inclusive
•Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, pulse, heart rate, temperature, well-being assessment and laboratory tests
•Able to provide written informed consent

•Any history of COPD, chronic bronchitis, emphysema, asthma , or any other lung disease, recent upper or lower respiratory tract infection, migraine headaches
•Concomitant drug therapy of any kind
•Who have taken any drug that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing
•Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
•Sensitivity to beclomethasone dipropionate any other similar class medicines or the excipients of beclomethasone dipropionate
•Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
•Concomitant drug therapy of any kind
•History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
•Females who are pregnant and/or are breastfeeding
•Who are planning to start a family within 60 days of receiving the final dose.
•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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