Clinical Research Directory

The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

Sponsor: Qilu Pharmaceutical Co., Ltd.

Summary

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.

Official title: A Single-dose, Randomized, Open-label, Three-period, Crossover Pharmacokinetic Study of QLC1101 in Healthy Subjects in the Fasting and Fed State

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