Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02196805
Eligibility Criteria:
Inclusion Criteria:
* Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
* Non-smokers
* Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
* Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
* Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
* Willing to adhere to the study procedures described in this protocol
Exclusion Criteria:
* History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
* Known hypersensitivity history to any prescription drug or over-the-counter medication
* Use of the following medications or products during the periods specified below:
Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration
* Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of the study
* Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the start of the study
* Body weight \<50kg
* History of drug abuse within past 5 years or positive urine drug screen results
* Subjects who test positive in HIV,HCV antibody,HBS antigen
* Otherwise judged by the investigator to be inappropriate for inclusion in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02196805
Study Brief:
Protocol Section:
NCT02196805