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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT03979859
Eligibility Criteria:
Inclusion Criteria:
* BMI : 18.0-30.0 kg/m2 (Body Mass Index \[BMI\] \[kg/m2\] = Body weight \[kg\] Height2 \[m2\])
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology as judged by the Principal Investigator
* Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
* Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be \<450 ms
Exclusion Criteria:
* Previous participation in the current study
* Evidence of clinically relevant pathology
* Mental handicap
* History of Myasthenia Gravis
* History of hepatitis and/or jaundice associated with the use of any antibiotic
* Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
* Smoking within 60 days prior to drug administration and through the follow-up visit
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03979859
Study Brief:
Protocol Section:
NCT03979859