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

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of clobazam (1 x 20 mg) on one occasion and the innovator formulation of clobazam (1 x 20 mg) on one occasion with each dose seperated by a three week washout period. The intervention for this trial is the test formulation of clobazam. 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 and will be monitored for 24 hours including pulse oximetry and vital sign for 8 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 health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose 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. CONDITION: Bioequivalence study conducted in healthy volunteers comparing two formulations of clobazam 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, clobazam is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox‐Gastaut syndrome (LGS) in patients 2 years of age or older. In New Zealand clobazam is a category C5 Controlled drug and is a Schedule IV controlled substance in the U.S. PRIMARY OUTCOME: To compare the bioavailability of clobazam (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for clobazam using one 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) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points. INCLUSION CRITERIA: Healthy male and non‐pregnant females Aged between 18 and 55 Non‐smoker BMI between 18 and 30 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent