A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects

Inclusion Criteria

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions and other study procedures.
• A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
• A participant with a Body Mass Index (BMI) of 18.5 to 30.0 kg/m^2; and a total body weight >50 kg
• Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 7 days after the last dose of assigned treatment.
• Participant with two consecutive negative tests for active COVID-19, separated by > 24 hours.
• Czech citizenship

Exclusion Criteria

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSKCH employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days before dosing.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A participant who is pregnant as confirmed by a positive hCG laboratory test or intending to become pregnant over the duration of the study.
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. This includes paracetamol and excipients in the products e.g. sorbitol, maltitol glycerol etc.
• A participant unwilling or unable to comply with Lifestyle Considerations.
• Diagnosis of long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
• A participant with evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance but not limited to any of the following:
• History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, e.g., appendectomy and herniorrhaphy)
• History of inflammatory bowel disease
• History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine (≥ 123 μmol/l) or urea (≥ 8.9 mmol/L) or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria);
• History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1)