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NOT YET RECRUITING
NCT07897240
PHASE1

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

Sponsor: Triastek, lnc.

View on ClinicalTrials.gov

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 PK parameters of D23A administered under fasted conditions versus fed conditions to see if a high-fat, high-calorie meal has a significant impact on the bioavailability and absorption kinetics of D23A . Participants will receive a single oral dose of 16 mg D23A (4 tablets) in each period of the crossover study, with one period under fasted conditions and the other under fed conditions (after consuming a high-fat, high-calorie meal) . The study will also monitor and record any adverse events (AEs) to evaluate the safety and tolerability of D23A under fed conditions .

Official title: A Single-Center, Randomized, Open-Label, Single-Dose, Two-Period, Two-Crossover Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-10

Completion Date

2026-12

Last Updated

2026-10-27

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Budesonide delayed release tablet

3D printing tablets

Locations (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China