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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT03798912
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent form
* Willing to comply with all study procedures and available for the entire duration of the study
* Age between 18 and 55 years
* BMI 17 - 32 kg/m2
* In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per investigator's judgment;
* Women of reproductive potential must use, between study day and the final study visit, a highly effective contraceptive, as defined in the Informed Consent Document, and have a negative urine pregnancy test at the time of screening, as well as on the day of study.
Exclusion Criteria:
* Unable to swallow an intact 000 capsule with water
* History of gastrointestinal surgery or illness, including diarrhea, constipation or other manifestations suggestive of abnormal digestion
* Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5 days of study day
* Barium ingestion within 30 days of study day
* Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex
* History chronic disease other than mild to moderate systemic hypertension
* Menstruation on day of dosing
* Pregnancy or lactating state
* Participation in an investigational or marketed drug trial within 30 days of the screening visit
* Low likelihood, in the investigator's judgment, to complete the study as required per study plan;
* Any other history which, in the investigator's judgment, makes the subject ineligible or exposes the subject to a risk;
* History of allergic reactions to a component of the RaniPill device or any allergic history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;
* Febrile illness within 5 days;
* History of drug or alcohol abuse or any other factor that, in the investigator's opinion, may interfere with the subject's ability to cooperate and comply with the study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03798912
Study Brief:
Protocol Section:
NCT03798912