None listed
Conditions
Brief summary
The purpose of our study is to investigate the absorption, safety and tolerability of 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine. In this study we will measure how much 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine is absorbed into the bloodstream and compare the concentrations between the test and reference formulations. This is called pharmacokinetics and refers to what happens to a medication from the time it enters the body until the exit of all traces of it.
Interventions
The intervention for this trial is the test formulation of 0.25 mL of 50 mg/mL 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension formulation.
Each dose is separated by a one week washout period.
No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose).
Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose.
Bathroom visits will be sup
The intervention for this trial is the test formulation of 0.25 mL of 50 mg/mL 3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine oral suspension formulation. Each dose is separated by a one week washout period. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized 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. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Screening and study exit laboratory tests will be completed to assess the health of the 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 that the medication has been taken as directed.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
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 18.5 and less than 30 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