Comparative assessment of the absorption of a generic formulation of N-acetyl-5-methoxytryptamine prolonged release tablet against the innovator N-acetyl-5-methoxytryptamine prolonged release tablet conducted under fed conditions in healthy male and female volunteers.
- Conditions
- -acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.N-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.Mental Health - Other mental health disordersNeurological - Other neurological disorders
- Registration Number
- ACTRN12622000966796
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for N-acetyl-5-methoxytryptamine using one fully validated LC/MS/MS method. Validation will be conducted to comply with TGA guidelines.[ -1, -0.5, 0 (pre-dose) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 18, 20 and 24 hours post dosing.]
- Secondary Outcome Measures
Name Time Method 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.[ -1, -0.5, 0 (pre-dose) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16, 18, 20 and 24 hours post dosing.]