Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
The main objective of the study is to evaluate the bioequivalence of a new formulation of
 ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg
 film-coated tablet, when administered under fasting conditions as single oral dose to healthy
 male and female volunteers, in two consecutive study periods.
Inclusion Criteria:

 1. Informed consent: signed written informed consent before inclusion in the study

 2. Sex and Age: males/females, 18-55 years old inclusive

 3. Body mass index (BMI): 18.5-30 kg/m2 inclusive

 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure
 (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the
 sitting position

 5. Full comprehension: ability to comprehend the full nature and purpose of the study,
 including possible risks and side effects; ability to co-operate with the investigator
 and to comply with the requirements of the entire study

 6. Contraception and fertility (females only): females of child-bearing potential must be
 using at least one of the following reliable methods of contraception:

 1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at
 least 2 months before the screening visit

 2. A non-hormonal intrauterine device [IUD] or female condom with spermicide or
 contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap
 with spermicide for at least 2 months before the screening visit

 3. A male sexual partner who agrees to use a male condom with spermicide

 4. A sterile sexual partner Female participants of non-child-bearing potential or in
 post-menopausal status for at least 1 year will be admitted. For all female
 subjects, pregnancy test result must be negative at screening and day -1.

 Exclusion Criteria:

 1. Electrocardiogram (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 or related drugs, namely non-steroidal anti-inflammatory
 agents (NSAIDs); history of anaphylaxis to drugs or allergic reactions in general,
 which the investigator considers may affect the outcome of the study

 5. Diseases: history of significant renal, hepatic, gastrointestinal (in particular
 gastroduodenal ulcer and bleeding), cardiovascular, respiratory (in particular
 asthma), skin, haematological, endocrine or neurological diseases that may interfere
 with the aim of the study

 6. Medications: medications, including over the counter medications (in particular
 ibuprofen) and herbal products 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 USDA Dietary Guidelines 2015-2020],
 caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 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 woman