IVIVR assessing PK parameters used to establish Bioequivalence

Exclusion Criteria

• - Subjects who test positive for the HLA-B*5801 allele.
• - Subjects who have received the last dose of an IMP (or treatment with a medical device) within the previous 3 months prior to Day 1 or is currently participating in another study of an IMP (or medical device).
• - History of any drug or alcohol abuse in the past 2 years.
• - Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
• - Current smokers and those who have smoked within the last 12 months prior to Screening. A breath carbon monoxide reading of greater than 10 ppm at Screening.
• - Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at Screening.
• - Clinically significant screening laboratory parameters (biochemistry [AST or ALT > 1.5 × ULN], hematology or urinalysis) as judged by the Investigator (laboratory parameters are listed in Appendix 1).
• - Positive drugs of abuse test result during Screening or at Admission (drugs of abuse tests are listed in Appendix 1).
• - Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
• - Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• - History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the Investigator.
• - Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of <90 mL/min using the Cockcroft-Gault equation.
• - Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• - Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hayfever is allowed unless it is active.
• - Donation or loss of greater than 400 mL of blood within the previous 3 months prior to Screening.
• - Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (See Section 11.4).