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Clinical trial

Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects

iX Biopharma Ltd.Not yet recruitingPhase 1Started Jun 9, 202614 enrolledAustraliaNCT07691372

Abstract

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.

Topics & conditions

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Ketamine

Keywords

PharmacokineticsSublingualWaferPhase 1Healthy VolunteersWafermineHealthy Adult Participants

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