A single dose, randomized, open-label, three-way crossover study to assess bioequivalence of paracetamol orodispersible tablets 500 mg vs Apiretal® 100 mg/ml oral solution in healthy volunteers under fasting conditions

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• Subjects who fulfil or develop during the study one or more of the following criteria are NOT eligible to participate in this study: 1.- Background of allergy, idiosyncrasy or hypersensitivity to IMP or any related products (including excipients of the formulations). 2.- Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3.- Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men or 24 gr/day for women.4.- Intake of any medication within 14 days prior to taking the study treatment (except for use of ibuprofen short-term symptomatic treatments, according to the investigator criteria), or intake of over-thecounter products (including natural food supplements, vitamins and medicinal plants products) within 7 days prior taking the study treatment. 5.- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. 6.- Positive results for abuse drugs in urine test or ethanol in breath test (Day-1). 7.- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases. 8.- Females with positive results from the pregnancy test or breast-feeding. 9.- Smoking within 6 months prior to the study treatment phase (Period 1, Day -1). Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment. 10.- To have participated in another clinical trial during the 3 months prior to study start (screening visit) in which an investigational drug, medical device or a commercially available drug was tested. 11.- To have donated blood within the 4 weeks period before screening visit. 12.- Having undergone major surgery during the previous 6 months before screening visit, or have an intervention programmed during the study. 13.- Mentally or legally incapacitated at screening. 14.- Unwillingness or inability to follow the procedures outlined in the protocol. 15.- Volunteers who have difficulties in understanding the language in which the volunteer information is given. 16.- Any condition that, in the opinion of the investigator, may jeopardise the patient’s well-being or the trial conduct according to the protocol.