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

Multiple dose, crossover over study design whereby each participant receives the test formulation of melatonin (1 x 2 mg) on five occasions and the innovator formulation of melatonin (1 x 2 mg) on five occasions with each dose seperated by a 10 day washout period. Each dose (1 x 2 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.