An open-label, single sequence study to assess the potential pharmacokinetic drug-drug interaction of elinogrel and atorvastatin at steady-state in healthy adult subjects

ovartis Pharmaceutical Pty Limited0 个研究点目标入组 28 人开始时间: 2011年3月24日最近更新: 2020年1月13日

适应症

试验速览

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•Healthy male and female subjects aged 18 to 45 (inclusive), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline. All evaluations must be within normal range for age and gender, or considered ‘not clinically meaningful’ if outside the normal range.
•Body mass index (BMI) must be 18 – 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.
•Vital signs (after 3 minutes in seated position) must be within stated ranges.

•PT (INR), aPTT, platelet count, bleeding time (in excess of 10 min), stool occult blood and microscopic hemoglobinuria, at screening or baseline are outside the normal range of the laboratory. INR below the lower limit of the local laboratory normal range isacceptable (but no lower than 0.9) at the investigators discretion.
•Facial or head trauma, intraocular hemorrhage, fractures within 30 days of Screening.
•History of any prior ischemic stroke or TIA within the last 5 years or intracranial hemorrhage, neoplasm, arteriovenous malformation, bleeding disorder or coagulation disorders which is considered clinically significant by the investigator.
•Known contraindication to the investigational compound, compound class (e.g. atorvastatin, clopidogrel glycoprotein IIb/IIIa inhibitors etc.).

发起方

ovartis Pharmaceutical Pty Limited