Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)

Exclusion Criteria

• •1. Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities
• •2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
• •3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
• •4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
• •5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
• •6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
• •7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
• •8. Blood donation: blood donations for 3 months before this study
• •9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>1 drink/day for females and \>2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010\], caffeine (\>5 cups coffee/tea/day) or tobacco abuse (≥6 cigarettes/day)
• •10. Drug test: positive result at the drug test at screening or day-1
• •11. Alcohol test: positive alcohol breath test at day -1
• •12. Diet: abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
• •13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women