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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04100759
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects
* Age 18-55 years.
* Ideal weight with ideal body mass index(BMI).
* Non-contributory history and normal physiological examination.
* Laboratory data within normal limits.
* Performance and compliance.
* The subjects should be without known history of alcohol or drug abuse problems
* Subjects who are cigarette smokers
* Subjects who are cannabis smokers
* Subjects who are non-smokers
Exclusion Criteria:
* A known hypersensitivity to the drug.
* Gastrointestinal diseases.
* Auto immune diseases.
* Renal diseases or dysfunction.
* Cardiovascular disease of any type.
* Pancreatic disease including diabetes.
* Hepatic disease.
* Hematological, osteopathic, or pulmonary disease.
* History of alcoholism or drug abuse.
* Serious Psychological illness.
* Positive HIV.
* Abnormal (out of range) laboratory values.
* Subject who have taken any medication less than two weeks of the trials starting date.
* Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04100759
Study Brief:
Protocol Section:
NCT04100759