None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of the reference formulation in fasting and steady state conditions, following oral administration of a N-acetyl-5-methoxytryptamine prolonged release tablet. In this study we will measure how much N-acetyl-5-methoxytryptamine is absorbed into the bloodstream and compare the concentrations between the test and reference formulations.
Interventions
Multiple dose, crossover study design whereby each participant receives the test formulation of 2 mg N-acetyl-5-methoxytryptamine prolonged release tablet on five occasions and the innovator formulation of 2 mg N-acetyl-5-methoxytryptamine prolonged release tablet on five occasions with each dosing period. There will be a minimum of 10 days between each dosing period. The intervention for this trial is the test tablet formulation.
On study days 1-5 participants will receive 5 daily doses of one
Multiple dose, crossover study design whereby each participant receives the test formulation of 2 mg N-acetyl-5-methoxytryptamine prolonged release tablet on five occasions and the innovator formulation of 2 mg N-acetyl-5-methoxytryptamine prolonged release tablet on five occasions with each dosing period. There will be a minimum of 10 days between each dosing period. The intervention for this trial is the test tablet formulation. On study days 1-5 participants will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test). No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose on study days 1 to 4 and 15 to 18. 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. 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 subjects are required to fast for 10 hours prior to receiving the dose and 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 12 hours prior to dosing to ensure compliance and for 24 hours after dosing. Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing and Urine Drugs of Abuse will be performed upon each participant reporting to the Clinical Site 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.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males and females Aged between 18 and 55 years Non-smoker BMI greater than or equal to 18 and less than 33 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Drug free as determined by urine drug testing Able to comply with the study restrictions Able to provide written informed consent
Exclusion criteria
Clinically significant medical conditions History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug History of alcohol or drug abuse or dependency Participation in a drug study within 30 days of the start of the study Sensitivities to the study drug or excipients Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Outcome results
None listed