Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

Inclusion criteria

• Male or female study participants, aged 18 years-old and above; women cannot be pregnant or breastfeeding;
• Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2;
• 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;
• 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;
• Subject does not present intact superior gastrointestinal mucosa, i.e., presenting bleeding, ulcers and apparent injuries in baseline endoscopy;
• Subject has achlorhydria (intragastric pH > 6.5);
• History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism;
• Chronic therapy with any drugs, except oral contraceptives;
• History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure;
• Occult blood in the stool before treatment;
• Electrocardiographic findings that, at investigator criteria, are not recommended for study participation;
• Deviations on screening laboratory results that are considered as clinically relevant by the principal investigator;
• 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 6 months before this 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.