A randomized, single-dose, single blind, placebo controlled, cross over, validation study of moxifloxacin induced QT/QTc changes in healthy subjects of Indian origin (Indian subcontinent)

ovartis Healthcare Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and/or female subjects, from 18-55 years of age and in good health.
•2. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.5 to 32 kg/m2
•3. Female subjects must be: Surgically sterilized at least 6 months prior to study participation or Post-menopausal or must be using two acceptable barrier methods of contraception

•1. Use of any prescription drug
•2. Participation in any clinical investigation
•3. QTcF at screening prolonged and past medical history of clinically significant ECG abnormalities
•4. Donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
•5. Significant illness within the 2 weeks prior to initial dosing
•6. History of or presence of risk factors for Torsade de pointes (TdP), including a family history of arrhythmia or sudden death, hypokalemia, hypomagnesia, family history of long QT syndrome
•7. History of diabetes mellitus
•8. History of hyperthyroidism
•Other exclusion critirea from protocol is applicable.

发起方

ovartis Healthcare Private Limited