A study comparing two formulations of R-107 under fasting conditions

This Phase I crossover trial (n=34) will compare the bioavailability of two ketamine formulations (R-107-H vs R-107-P) in healthy volunteers under fasting conditions.

This randomized, double-blind study compares two extended-release tablet formulations containing ketamine, both administered as 3 x 60mg tablets (180mg total dose). The study will take place at Zenith Technology Corporation in Dunedin, New Zealand. The main goal is to determine if the test formulation (R-107-H) has similar bioavailability to the reference formulation (R-107-P) by measuring blood and urine levels of ketamine and its metabolite norketamine over 48 hours after dosing.

Secondary outcomes include safety and tolerability assessments through monitoring of adverse events, vital signs, ECG, and psychiatric rating scales. The study will involve healthy male and female volunteers aged 18-55 with a BMI between 18.5-33.0. Each participant will receive both formulations in random order with at least a one-week washout period between doses. The total study duration is approximately 6 weeks per participant, including screening and follow-up periods.

Topic Depression
Compound Ketamine
Country New Zealand
Visit trial
Status Planned
Results Published No
Start date 09 October 2024
End date 31 December 2025
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 34
Sex All
Age 18- 55
Therapy No

Trial Details

The primary objective of this study is to evaluate the comparative bioavailability of the test formulation relative to that of a reference formulation, following oral administration of a single dose of 3 x 60 mg R-107-H extended release tablets and 3 x 60 mg R-107-P extended release tablets in healthy participants under fasting conditions. In lay terms this means we are comparing one R-107 formulation (R-107-H) to another R-107 formulation (R-107-P) that both contain the same amount of active ingredient but some of the other ingredients differ between the two making them different formulations of the R-107 extended-release tablet.

NCT Number

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.