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:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03714568
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female, age 18 to 60 years, inclusive.
* The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\~26.
* Adequate blood cell counts, kidney function and liver function.
* Healthy participants should participate in the study voluntarily and sign informed consent.
Exclusion Criteria:
* Subjects with known allergy to the similar products tested.
* Subject is on a special diet (for example subject is vegetarian).
* Medical demographics with evidence of clinically significant deviation from normal medical condition.
* Female subjects who were pregnant or nursing.
* Results of laboratory tests which are clinically significant.
* Acute infection within one week preceding first study drug administration.
* History of drug or alcohol abuse.
* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
* ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03714568
Study Brief:
Protocol Section:
NCT03714568