Status: Not yet recruiting
Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects
This is a Phase 1, open-label, three-period crossover study evaluating the pharmacokinetics and safety of single-dose Wafermine™ (ketamine sublingual wafer) at dose levels of 25 mg, 50 mg, and 75 mg in healthy adult participants under fasting conditions. Participants will receive all three dose levels in a fixed ascending sequence during a single inpatient admission, with washout periods between doses. Pharmacokinetic sampling will be conducted over 36 hours following each dose.
Participants needed: 14
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: iX Biopharma Ltd.Updated: Jul 8, 2026Locations: 1
Eligibility criteria
Clinically healthy participants (male and female) aged ≥ 18 to ≤ 65 years at the... [+32]
Research participants with inflammatory or ulcerative disease in the oral cavity... [+30]