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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01469520
Eligibility Criteria:
Inclusion Criteria:
* The eligibility criteria included adults between 22 and 55 years;
* Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;
* Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;
* Willing to be hospitalized for the 24-hour intensive sampling period.
Exclusion Criteria:
* The exclusion criteria was hypersensitivity to study drugs;
* Abnormal laboratory biochemistry values;
* Smokers;
* Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
* Treatment with experimental drugs within 30 days prior to study entry.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
55 Years
Study:
NCT01469520
Study Brief:
Protocol Section:
NCT01469520