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 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT04902534
Eligibility Criteria:
Inclusion Criteria:
* Subjects understand well trial purpose, nature, content, process and possible adverse reactions, and voluntarily sign an informed consent form.
* Healthy male or female aged between 18 and 65 years old (including the critical value).
* The body mass index is in the range of 19-26kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
* Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements, Chest X-ray, abdominal ultrasound and laboratory safety tests .
* The subjects have no family planning within 6 months and could select contraceptive method. They have no sperm and egg donation program.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
* The subjects could communicate well with researchers and complete the study according to the protocol.
Exclusion Criteria:
* Any history of hypersensitivity or idiosyncratic reactions to any food or drug, especially for drugs containing echinacoside.
* Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
* ALT or/and AST or/and TBIL ≤1.5 times the upper limit of normal Cr,BUN≥upper limit of normal, or Ccr≤80mL/min.
* Any history of acute or chronic illness that might affect drug absorption, and/or metabolism;
* Any history of drug abuse in the past 6 months or drug use 3 months prior to screening;
* Any history of alcohol abuse 3 months prior to screening or moderate drinkers (drink more 2 units per day or 14 units per week);
* Smoking more than 5 cigarettes per day during the 3 months prior to screening;
* Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
* Any use of other prescription drugs (including contraceptive)、over-the-counter drugs, Chinese herbal medicine, health care products and 14 days prior to medication for this study;
* Any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol products, grapefruit-containing or caffeine/xanthine-rich food and beverages 48 h prior to medication for this study;
* Dysphagia or having special dietary requirements;
* Occurring acute disease in the screening period or before the medication;
* Lactating or pregnant women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04902534
Study Brief:
Protocol Section:
NCT04902534