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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01093859
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers aged 18-45 (inclusive) years.
* Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.
* Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
* Blood pressure and heart rate within normal limits.
* Electrocardiogram (ECG) with no clinically significant abnormalities.
Exclusion Criteria:
* History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
* Current / previous occupational exposure to organophosphates or pesticides.
* Previous receipt of any investigational butyrylcholinesterase product.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01093859
Study Brief:
Protocol Section:
NCT01093859