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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT02713802
Eligibility Criteria:
Inclusion Criteria:
* Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.
Exclusion Criteria:
* Evidence or history of clinically significant disease.
* History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
* Pregnant or nursing (lactating) women.
* Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
* Family history of malignant hyperthermia.
* History of drug or alcohol abuse (or tests positive at screening) or current smoker.
* Poor venous access in either arm.
* Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.
Other protocol defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02713802
Study Brief:
Protocol Section:
NCT02713802