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.

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of 1 x 60 mg R‐192 tablet on one occasion and the test formulation R‐107 tablet on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test R‐192 formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the oral 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 supervised during the first 5 hours. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 56 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and drugs of abuse test 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. Both doses will be taken orally with 240 ml of water at ambient temperature. The R‐192 and R‐107 tablets must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. CONDITION: Mental Health ‐ Depression Mental Health ‐ Anxiety Depression;Anxiety; ; Depression ; Anxiety PRIMARY OUTCOME: 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: 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] INCLUSION CRITERIA: 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