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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03850834
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 18-45 years
* Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
* Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
* Sign the informed consent form voluntarily and cooperate voluntarily to complete the test
Exclusion Criteria:
* Allergens (allergic to 2 or more drugs, food or pollen)
* comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
* have Clinically significant abnormal screening laboratory values.
* Systolic pressure \> 140mmHg or diastolic \> 90 mmHg
* Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
* The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
* Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
* Have donated or lost blood 400 ml within 8 weeks prior to screening
* Participated in other clinical trials within 3 months prior to screening
* Intakes too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
* Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
* Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer halflife
* Using any psychotropic drug or psychoactive substance
* Women were screened for positive blood pregnancy
* The subjects and their partners were not willing to take contraceptives during trial and six months after the study
* Have a donor plan recently
* Have participated in this trial
* The researchers believe that anyone who is unfit to participate in this test will be involved
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03850834
Study Brief:
Protocol Section:
NCT03850834