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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05531994
Eligibility Criteria:
Inclusion Criteria:
* Fully understood and voluntarily signed the informed consent form
* With high compliance
* BMI 18.6-28.5 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
Exclusion Criteria:
* Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
* With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
* Had drug abuse within 3 months before screening or positive in drug of abuse test
* With any routine use of drugs
* Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
* With average number of cigarettes smoked \> 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
* With average alcohol consumption \> 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
* With average tea, coffee, or other drink with caffeine consumption \> 8\*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
* Lost or donated blood \> 200 mL within 3 months, or donated platelet \> 24 U within 1 months before study drug administration
* Received any drug within 14 days before study drug administration
* Received any drug of other clinical trial within 3 months before study drug administration
* Received any vaccine within 4 weeks before study drug administration
* Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
* For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
* For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05531994
Study Brief:
Protocol Section:
NCT05531994