A randomized, double-blind, placebo-controlled, 4-period cross-over drug-drug interaction study to evaluate the effect of sugammadex and aspirin on platelet aggregation and coagulation parameters in young healthy male volunteers - Aspirin interaction study

Schering-Plough0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Healthy male volunteers
•- 18-45 years of age
•- BMI 18-32
•- Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
•- No clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, coagulation, platelet count )
•- Normal physical examination (including vital sign measurements), normal ECG
•- Subject agrees to use one of the accepted methods of contraception

•- Clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, coagulation) or physical examination
•- Subject*s female partner is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
•- Drug or alcohol abuse
•- smoking more than 10 cigarettes per day.
•- Subject is not able to refrain from alcohol, grapefruit, xanthines as descibed in the protocol
•- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
•- history of an unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia.
•- history of anaphylaxis from any cause, a suspected history of hypersensitivity reactions to cyclodextrins, or multiple drug hypersensitivities.
•- allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the investigator, interfere with their ability to participate in the trial.

发起方

Schering-Plough