Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers

ano Daru pharmaceutical Co.0 个研究点目标入组 48 人开始时间: 待定最近更新: 2020年9月7日

试验速览

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•History of hypersensitivity to the study drug or related products.
•Significant history or presence of gastrointestinal, kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
•Significant history of asthma, chronic bronchitis or other broncho spastic condition.Significant history or presence of glaucoma, cardiovascular or hematological disease. Any clinically significant illness during the 4 weeks prior to day of this study.
•Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
•Participation in a clinical trial with an investigation drug within 30 days preceding day 1 of this study.
•Use of enzyme- modifying drugs within 30 days prior to day 1 of this study.
•Use of any systemic medication (including OTC preparations) within 14 days prior to day 1 of this study.
•HIV and Hepatitis B and anti HCV antibody positive subjects.
•History of difficulty in donating blood
•Donation of blood within 90 days before first dosing.
•History of vaccination within one month before first dosing.

发起方

ano Daru pharmaceutical Co.