Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers

You may not qualify if:

• History or presence of hepatic or biliary disease
• History of gastrointestinal surgery, specifically cholecystectomy
• History or presence of alcohol or drug abuse
• History or presence of neurological or psychiatric comorbidities, including psychological therapy
• Other clinically significant concomitant disease states (e.g., renal disease, cardiovascular disease, etc.)
• Intake of prescribed or over-the-counter medications, herbal preparations, and / or vitamin / dietary supplements
• Clinically relevant history or presence of allergy or asthma (in the opinion of investigator)
• Female volunteers: pregnancy as confirmed by laboratory assessment; breast-feeding
• Known hypersensitivity or allergy to class of drugs or the study product
• Women with intention to become pregnant during the course of the study,
• Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using two medically reliable methods of contraception for the entire study duration, or who are not using any other method considered sufficiently reliable by the investigator in individual cases, for the duration of the study from screening visit to 30 days after end-of-study-examination.
• Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.