Evaluation of Bioequivalence of ?Fenofibrate ??? mg in Healthy Volunteers

Aani ?Darman Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年5月29日

试验速览

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•18 to 55 years old, Males and/or non-pregnant, non-lactating females
•Body mass index (BMI) from 18.5 to 24.9 weight in kg/(height in meter), ability to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent
•having a physical examination with no clinically significant finding and laboratory normal tests,
•do not take any chronic or acute medication for at least 1 week before the start of the study
•no history of diseases affecting the pharmacokinetic processes of the drug

•History of allergic responses to related drugs, or any of its formulation ingredients,
•have significant diseases (which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system) or clinically significant abnormal findings during screening, history or presence of bronchial asthma
•history or evidence of drug dependence or of alcoholism or of moderate alcohol use, smokers who smoke 10 or more cigarettes per day or those who cannot refrain from smoking during the study period,
•history of difficulty with donating blood or difficulty in accessibility of veins,
•history of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
•volunteers who have received a known investigational drug within five elimination half-life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater,
•found positive in urine test for drugs of abuse done before check-in of period,

发起方

Aani ?Darman Pharmaceutical Company