This randomized, open-label, three-period, three-treatment crossover Phase I clinical trial is designed to evaluate the pharmacokinetic profile of QLC1101 capsules administered as a single oral dose under fasting conditions, following a high-fat meal, and following a low-fat meal in healthy adult subjects. The study will further characterize the food effect on QLC1101 pharmacokinetics. A total of 18 eligible subjects will be enrolled and randomized into three treatment sequences (A, B, C) using a balanced crossover design, with 6 subjects per sequence. The study comprises three treatment periods separated by appropriate washout intervals. In each period, subjects will receive a single dose of QLC1101 under one of three distinct dietary conditions according to their assigned sequence. Following completion of the first treatment period and a washout phase, subjects will crossover to the next dietary condition in the subsequent period, with this process repeating through all three study periods.
Age range
18 Years – 45 Years
Sex
ALL
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Cmax
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
AUC
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
Tmax
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
t1/2
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
CL/F
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
VZ/F
Timeframe: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose