None listed
Conditions
Brief summary
The objective of this study is to evaluate the comparative bioavailability of the test formulation relative to the that of a reference formulation, following oral administration of a single dose of R107 tablet or ketamine IV solution to healthy male and female subjects under fasting conditions.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of R107 tablet on one occasion and the innovator formulation of 60 mg ketamine IV solution on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test R107 formulation.
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
Single dose, crossover study design whereby each participant receives the test formulation of R107 tablet on one occasion and the innovator formulation of 60 mg ketamine IV solution on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test R107 formulation. 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 and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 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. The R107 tablet must be swallowed whole and the IV Solution will be administered through a syringe and a mouth check will be conducted to ensure 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 non-pregnant female volunteers. Aged between 18 and 55 Non-smoker BMI between 18.5 and 30 Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests The absence of mental illness requiring medication or treatment by a physician. Able to provide written informed consent
Exclusion criteria
Concomitant drug therapy of any kind Any history of mental illness requiring medication or treatment by a physician. Receiving treatment with monoamine oxidase inhibitors, vasoconstriction agents, thyroxine or benzodiazepines. m) History of significant drug abuse or dependency including ketamine or its excipients within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening. Sensitive to the study drug History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Females who are pregnant and/or breastfeeding Smoker (anyone who has smoked in the last 6 months) History of alcohol or drug abuse or dependency Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
Outcome results
None listed