Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug (ACH15)

Inclusion Criteria:

• Male patient, aged between 18 and 50 years;
• Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2;
• Healthy men accordance with their historical and tests;
• Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol
• Negative results for parasitological stool examination performed in the clinical study;
• Subject of research with laboratory results within the normal range for urinalysis collected before the first visit;
• Research subjects allocated in Group 6 with endoscopy within the normal range;

Exclusion Criteria:

• History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma;
• Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality;
• History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study;
• Use of any medication two (2) weeks prior to inclusion of the research subject in the study;
• Regular smokers or who quit less than one (1) year;
• History of food allergy or hyperreactivity to medications or foods;
• HIV positive for HIV;
• Being positive for Hepatitis B;
• Being positive for hepatitis C;
• Testing positive for Helicobacter pilorum;
• Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form);
• Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form;
• Subject with a history of hypersensitivity to any component of the investigational product;