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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT03807050
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male volunteers between 18 and \<46 years of age.
2. Subjects who provide written informed consent to participate in the study.
3. BMI ranging from 18.0 to \<30.0, calculated as Weight (Kg)/Height (m2).
4. Non-smoking (by declaration) for a period of at least 6 months.
5. No known history of significant neurological, renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine, gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
6. No history of drug or alcohol abuse.
7. No known allergy or hypersensitivity to any drug or food.
8. No clinically significant abnormalities in screening physical exam.
9. No clinically significant abnormalities in clinical laboratory parameters (hematology, biochemistry and urinalysis) at Screening, as determined by the study physicians.
10. Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at Screening.
11. No significant abnormalities in electrocardiogram.at Screening.
12. Subjects with negative urinary drugs of abuse screen determined at Screening and on admission to the clinical research center prior to dosing day.
13. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
14. Subjects must satisfy a medical examiner about their fitness to participate in the study.
Exclusion Criteria:
1. Subjects with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
2. Subjects with a history of clinically defined peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence supplement absorption, or with any history of severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
3. Subjects with significant allergic response to any drug or history of food allergies deemed clinically significant or exclusionary for the study.
4. Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the study, or subjects with recent significant change in body weight.
5. Treatment with prescription or over-the-counter drugs, nutraceuticals including vitamins, herbal medications, food supplements and other prescription drugs not mentioned above, within 7 days prior to first dosing day.
6. Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.
7. Subjects who donated blood or received blood or plasma derivatives in the three months preceding the first study dosing.
8. Participation in another clinical trial with drugs within 3 months prior to first study dosing day (calculated from the previous study's last dosing date).
9. Subjects with an inability to communicate well with the investigators and Clinical research Center staff (i.e., language problem, poor mental development or impaired cerebral function).
10. Subjects that have difficulty fasting or consuming the standard meals that will be provided.
11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
12. Subjects who are non-cooperative or unwilling to sign the consent form.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT03807050
Study Brief:
Protocol Section:
NCT03807050