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Food Effects on Bioavailability of MDMA in Healthy Volunteers (MPKF)
CompletedRegisteredCTG
Phase I open-label randomized, two-period crossover PK study (n=14) comparing oral MDMA 100 mg under fed versus fasted conditions in healthy volunteers to assess food effects on bioavailability and safety.
Details
Randomized sequence, two-period crossover comparing fasted (≥10 h) and fed (high‑fat, 800–1000 kcal) conditions; each period includes a single oral dose of MDMA (100 mg midomafetamine, ≈120 mg HCl equivalent).
Participants are confined at the clinical research unit from check-in the night before dosing until at least 48 hours after dosing for PK sampling (0–72 h) and safety monitoring; an additional outpatient visit at 72 hours collects final PK and safety assessments.
Topics:Healthy Volunteers
Registry
Registry linkNCT05147402