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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT03633760
Eligibility Criteria:
Inclusion Criteria:
1. Ethnic Chinese males and females between 18 and 45 years of age (inclusive).
2. Having voluntarily given their informed consent to participate in the study after receiving information about the design, aims and potential risks that could result from the study and being informed that they could refuse to take part in or withdraw from the study at any time.
3. Body mass of no less than 50 kg. Body mass index: 19 to 24 kg/m2 (inclusive).
4. No clinically significant abnormal findings from the physical examination, vital signs check, electrocardiogram (ECG), medical history, or clinical laboratory results during screening and pre-dosing of Day 1.
5. A negative screen for HIV and hepatitis B.
6. A negative urine or breathalyzer screen for alcohol and negative urine screen for drugs of abuse.
7. Are non-tobacco / nicotine users (within 3 months prior to screening visit).
8. A negative serum pregnancy test for female subjects.
9. Subjects who are willing to comply with the contraception restrictions for this study:
1. True abstinence.
2. Barrier methods with spermicidal use. The use of barrier contraceptives should always be supplemented with the use of a spermicide, where available.
3. Intrauterine devices: intrauterine device with the use of condom or spermicide.
4. Sterilization of male subjects (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
Exclusion Criteria:
1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, haematological, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, jeopardises the safety of the subject or will impact the validity of the study results.
2. History of allergic or adverse response to antihistamine drugs.
3. Participated in a clinical trial within 90 days prior to screening.
4. Donated blood within 90 days prior to screening.
5. Donated plasma within 90 days prior to screening.
6. Abnormal diet or substantial changes in eating habits within 30 days prior to screening.
7. Used any prescription medication within 14 days prior to or during screening, especially any known P-glycoprotein transporter inhibitors agents (ketoconazole, erythromycin, ciclosporin, digoxin, etc.).
8. Used any prescription or any over-the-counter medication, herbal or traditional Chinese medication within 7 days prior to or during screening.
9. Intake of grapefruit or any other citrus fruit, fruit juice or cranberries within 72 hours prior to study drug administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03633760
Study Brief:
Protocol Section:
NCT03633760