Bioequivalence assessment of generic darifenacin [Darisec(R - registered trademark) ] vs. innovator darifenacin [Enablex(R - registered trademak)] in healthy volunteers.

Center for Clinical Pharmacology Research Bdbeq S.A.0 个研究点目标入组 24 人开始时间: 2010年10月19日最近更新: 2020年1月13日

试验速览

暂无简介。

•BMI>18.5 and <29.9 kg/m2
•Healthy based in medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
•Able to comply wiht study procedures.
•Able to give informed written consent for participation in the study.

•Known hypersensitivity or idiosyncratic reaciton to darifenacin or any related drug.
•Resting heart rate > 70 bpm.
•Pregnant or breast-feeding.
•Ingestion of medicines at any time within 14 days before the inception of the trial.
•A recent history of alcoholism (<2 years) or of moderate alcohol use (180 ml/day), or consumption of alcohol within 48 hours prior to the start of the study.
•Smoker, more than 10 ciegarrettes per day.
•Presence of clinically significant abnormal laboratory values during screening.
•History of drug addiction or testing positive in pre-study drug scan.
•Donation of blood (350 ml) within 90 days prior to receiving the study drug.
•History of psychiatric disorder.

发起方

Center for Clinical Pharmacology Research Bdbeq S.A.