The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

Launched by QILU PHARMACEUTICAL CO., LTD. · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Food Effect on Pharmacokinetics Study of QLC1101, is looking at how food impacts the way a medication called QLC1101 is absorbed by the body. The study involves healthy adult volunteers who will take the medication in different situations: when they haven't eaten, after a high-fat meal, and after a low-fat meal. By comparing these different scenarios, researchers hope to learn how food affects the medication's performance in the body.

To be eligible for this study, participants should be between the ages of 18 and 65 and meet certain health criteria, such as having a healthy weight (for example, men should weigh at least 110 pounds and women at least 99 pounds). Participants will take the medication three times in total, each time under different eating conditions, with breaks in between. It's important to note that individuals with a history of allergies to drugs or food, or certain medical conditions that affect how drugs are absorbed, won't be able to participate. Overall, this study is crucial for understanding how food interacts with QLC1101, which could help in its future use for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg.
• • BMI is within the range of 18.0\~28.0 kg/m2 (including the boundary value).
• Exclusion Criteria:
• • Those who have a history of allergies to drugs, food, pollen, or other clear allergies, or those who are allergic to the experimental drugs and their ingredients;
• • Patients with dysphagia or any disease that affects drug absorption, distribution, metabolism and excretion, especially those with a history of gastrointestinal diseases (such as gastric ulcer, gastric bleeding, long-term diarrhea, etc.)