This open-label, randomised, four-way crossover, single dose study (n=16) aimed to investigate the safety, tolerability, and pharmacokinetics of different oral thin film (OTF) formulations of (S)-ketamine for sublingual administration in healthy participants.
Randomised, four-period crossover in healthy adults to characterise plasma pharmacokinetics of four single-dose sublingual oral thin film (S)-ketamine formulations (OTF 1–4) with at least 72 hours washout between periods.
Primary assessments are PK parameters after each single-dose administration; safety and tolerability monitored via labs and clinical assessment. Key eligibility: BMI 20.0–28.0 kg/m^2, weight 60–100 kg, nonsmokers, females require negative pregnancy tests.
Four-period randomised crossover comparing four single-dose sublingual OTF formulations (OTF1–OTF4) with ≥72-hour washout between periods.
Four OTF formulations (OTF 1–4); per-formulation doses not specified; primary outcome PK profile.