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

Not yet recruitingRegisteredANZCTR

Phase I randomised, blinded crossover PK/bioavailability study (n=34) comparing R-107-H (3×60 mg) versus R-107-P (3×60 mg) in healthy volunteers under fasting conditions.

Details

Randomised, blinded, two-period crossover in healthy volunteers to compare bioavailability (AUC0-t, Cmax) of two extended-release ketamine formulations given as a single oral dose (3 × 60 mg = 180 mg) under fasting conditions.

Study duration ≈6 weeks including screening; each treatment period spans 3 days with dosing on Day 1 and intensive PK sampling (urine and plasma) including pre-dose and multiple post-dose windows up to 48 hours; minimum 1-week washout between periods.

Topics:Healthy Volunteers

Registry

Registry linkACTRN12624001308583