A Ranomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a 16.53 mg Pioglitazone HCl/500 mg Metformin HCl Extended Release Tablet Compared with a 16.53 mg Pioglitazone Tablet and 500 mg Metformin HCl Extended Release Tablets under Fed Conditions in Healthy Male Subjects

Chungnam National University Hospital0 个研究点目标入组 50 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•1. Healthy male volunteers between the ages of 20 and 55 years at screening
•2. Volunteers with a body weight within ± 20% of their ideal weight and over 55kg
•3. Subjects have to be able to read, hear, and understand the detail of the study, and should decide to participate in the study volntarily and follow the study directions and provide written informed consent

•1. History of hypersensitivity to pioglitazone HCl or metformin HCl
•2. Volunteers with systolic blood pressure = 100 mmHg or = 150 mmHg, or diastolic blood pressure = 50 mmHg or = 145 mmHg, or with pulse rate < 45 bpm or > 100 bpm
•3. Volunteers with serum creatinine = 1.5 mg/dL
•4. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant disease
•5. Volunteers with atrial and ventricular displacement, atrial fibrillation or flutter, ventricular tachycardia and ventricular fibrillation, or multifocal ventricular ectopic beats, QT interval prolongation
•6. History of gastrointestinal disease or resection operation
•7. History of alcohol abuse or excessive smoking, or subjects who are not willing to abstain from drinking or smoking for the duration of study
•8. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
•9. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
•10. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
•11. Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to scheduled study drug administration
•12. Current or previous abuse of drugs or alcohol

发起方