Comparative assessment of the absorption of a generic formulation of desvenlafaxine extended release tablet against the innovator desvenlafaxine extended release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers

INTERVENTION: Multiple dose, crossover over study design whereby each participant receives the test formulation of desvenlafaxine (1 x 100 mg) on five occasions and the innovator formulation of desvenlafaxine (1 x 100 mg) on five occasions with each dose seperated by a 10 day washout period. Each dose (1 x 100 mg) will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. Participants are required not to eat for 10 hours before receiving each dose. On study days 1 to 4 and 15 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample. They will then be given a light breakfast to consume following each dose at home. On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing. On study days 5 and 19 standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing on study days 5 and 19. Pre and post study laboratory tests will be completed to assess the healthy of participants along with HIV, Hepatitis and drugs of abuse testing. CONDITION: Bioequivalence study conducted in healthy volunteers comparing two formulations of desvenlafaxine with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, desvenlafaxine belongs to a class of medicines called Serotonin‐Nonadrenaline Reuptake Inhibitors and is an antidepressant prescribed for the treatment and prevention of relapse of depression. PRIMARY OUTCOME: To compare the bioavailability of O‐desmethylvenlafaxine (as summarised by AUC0‐t(ss), Cmax(ss) and Cmin(ss)) for the two formulations. All plasma samples will be assayed for O‐desmethylvenlafaxine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. INCLUSION CRITERIA: Healthy males and Females Aged between 18 and 55 Non‐smoker BMI between 19 and 30 Normal, healthy individuals as determined by medical history, physical examination, ECG, bood pressure and laboratory tests Able to provide written informed consent