Crossover, Single Dose Randomized, Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Oral Solution

Exclusion criteria

• . Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities
• . Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
• . Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
• . Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study
• . Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine or neurological and autoimmune diseases that may interfere with the aim of the study
• . Medications: medications, including over the counter (OTC) drugs \[in particular ketoprofen and acetylsalicylic acid (ASA) and NSAIDs in general\], herbal remedies and food supplements taken 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
• . 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 (date of the informed consent signature)
• . Blood donation: blood donations for 3 months before this study