Clinical Trial: A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants

U.S., Oct. 28 -- ClinicalTrials.gov registry received information related to the study (NCT07897240) titled 'A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants' on Oct. 13.

Brief Summary: The goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants. The main questions it aims to answer are :

(1) Does a high-fat, high-calorie meal significantly alter the plasma exposure (Cmax, AUC) of budesonide following oral administration of D23A? ( 2) How does food intake affect the absorption rate (Tmax, Tlag) and other PK parameters of D23A? Researchers will compare the plasma P...