Status:
NOT_YET_RECRUITING
The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Effect of Food
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06980909
Start Date
June 1 2025
End Date
August 1 2025
Last Update
May 20 2025
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