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A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

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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.

Details

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.

Topics:Healthy Volunteers

Registry

Registry linkNCT04300621