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.
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.
Overnight fast (≥10 h) then 100 mg midomafetamine (120 mg HCl equivalent) with 240 mL water; no food ≥4 h post-dose.
100 mg midomafetamine (≈120 mg midomafetamine HCl); given after ≥10 h fast; 240 mL water; no food ≥4 h post-dose.
High-fat, high-calorie meal (≈800–1000 kcal, ~50% fat) consumed; 100 mg midomafetamine administered 30 minutes after start of meal.
Meal consumed within 30 minutes; 100 mg midomafetamine given 30 minutes after meal start; 240 mL water.