Comparative assessment of the absorption of a generic formulation of tibolone tablet against the innovator tibolone tablet conducted under fasting conditions in healthy female volunteers

INTERVENTION: Single dose, crossover over study design whereby each participant receives the test formulation of tibolone (1 x 2.5 mg) on one occasion and the innovator formulation of tibolone (1 x 2.5 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of tibolone. Each dose (1 x 2.5 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. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and 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 28 hours after dosing. 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. 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 tibolone 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, tibolone belongs to a class of medicines called synthetic steroid hormone drugs and is prescribed for the short‐term treatment of symptoms due to natural or surgical menopause. PRIMARY OUTCOME: To compare the bioavailability of tibolone (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for tibolone 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 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 Not currently using any prescribed hormonal contraceptive Able to provide written informed consent