NL-OMON28697已完成不适用
A FIXED-SEQUENCE CROSSOVER, DRUG-DRUG INTERACTION STUDY IN HEALTHY SUBJECTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
o
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects enrolled in the study were required to meet all the following criteria for study entry:
- •Men or women of any race, between 18 and 50 years of age, inclusive, at screening
- •BMI between 18.0 and 31.0 kg/m2, inclusive, and a body weight of at least 50.0 kg at Screening
- •In good health determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
- •All clinical laboratory tests must be within normal limits or no clinically significant abnormalities
排除标准
- •Subjects who met any of the following criteria were excluded from study entry:
- •History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders as determined by the investigator
- •Abnormal vital signs at screening
- •Clinically significant neurologic disorder
- •Evidence of ANY hepatic impairment
- •Clinically significant ECG abnormality at screening
- •History of clinically significant congestive heart failure.
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