Actively Recruiting
Phase 1 Study to Assess How Food Affects the Absorption of CX11 Tablets in Healthy Adults Aged 18 to 45
Led by Vincentage Pharma Co., Ltd · Updated on 2026-03-27
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating how food affects the way the body processes CX11 tablets in healthy adults aged 18 to 45. This Phase 1 study focuses on understanding the impact of food intake on the drugs absorption, concentration, and timing in the bloodstream. The study includes participants with a body mass index BMI between 20 and 28 who are otherwise healthy and meet specific weight requirements. Participants will receive CX11 orally over two cycles in a randomized, open-label, crossover design. One group will take the drug first while fasting then while fed, and the other group will follow the opposite order. Each cycle includes seven days of dosing with the drug given in different fed or fasted states to compare how food intake influences the drugs pharmacokinetics. Throughout the study, participants will have blood samples taken to measure drug levels, including the area under the concentration-time curve AUC, maximum concentration Cmax, and time to maximum concentration Tmax over 35 days. Safety and adherence will be monitored, with the total participation lasting through the dosing and follow-up periods to assess how food affects the drugs behavior in the body.
CONDITIONS
Brief Title
A Food-Effect Study of CX11 in Healthy Participants
Research Team
W
Wang
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