Comparative bioavailability assessment between 1 x 60 mg R-192 tablet and 1 x 60 mg R-107 tablet administered orally in healthy participants under fasting conditions.
- Conditions
- DepressionAnxietyMental Health - DepressionMental Health - Anxiety
- Registration Number
- ACTRN12622000446763
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 14
Healthy participants.
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30
Healthy individuals in good health 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
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.
History of significant drug abuse or dependency including R-107 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.
Significant current risk of suicide as assessed by eC-SSRS, or serious risk for suicide, as assessed by the evaluating study clinician.
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Participants of child- bearing potential who are pregnant and/or breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol 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
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). All plasma samples will be assayed for 2-amino-2-(2-chlorophenyl)cyclohexan-1-one, 2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one and cis-6-Hydroxynorketamine hydrochloride using fully validated LC/MS/MS methods. Validation will be conducted to comply with FDA guidelines.[ 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 28, 32, 48 and 56 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.[ 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 28, 32, 48 and 56 hours post dosing]