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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02667535
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged ≥ 18 years-old;
* Body mass index (BMI) ≥ 19 Kg/m2 and ≤ 35 Kg/m2;
* For healthy volunteers: good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory tests;
* For participants with the condition under study: anal fissure;
* Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Exclusion Criteria:
* Known hypersensitivity to the investigational products (naproxen or rebamipide) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
* Chronic therapy with any drugs, except oral contraceptives and medication authorized by principal investigator (each case to be individually evaluated);
* History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, or any other co-morbidity that requires priority immediate treatment ot that, at principal investigator discretion, might interfere with study participation or expose study participant to risks other than predicted;
* Deviations on screening laboratory results that are considered as clinically relevant by the principal investigator;
* Smoking;
* History of drugs and alcohol addiction or excessive alcohol consumption (\> 35 g/ day);
* Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed;
* Treatment, within 6 months before the trial, with any drugs known to have a well established toxic potential to major organs;
* Participation in any other experimental research or administration of any experimental drug within six months before this trial;
* Donation or loss of 450 mL of blood (or more) within 3 months before the trial, or 4 donations within 12 months before the trial;
* Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial;
* Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02667535
Study Brief:
Protocol Section:
NCT02667535