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The Food Effect on Pharmacokinetics of DA-302168S

NCT06534346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-16

No results posted yet for this study

Summary

This study will be conducted to determine the effect of food on the pharmacokinetics characteristic of DA-302168S following administration of a DA-302168S tablet with and without a high-fat meal.

Conditions

  • Overweight and Obesity

Interventions

DRUG

15 mg DA-302168S tablet

Qualified subjects will be randomly assigned to one of two dosing sequences in a 1:1 ratio. Either DA-302168S tablet with food on Day 1 and DA-302168S tablet without food on Day 6 (treatment sequence fed/fasted), or DA-302168S tablet without food on Day 1 and DA-302168S tablet with food on Day 6 (treatment sequence fasted/fed). Each administration sequence consists of two cycles, with one administration per cycle and a 5-day washout period between each administration.

Sponsors & Collaborators

  • Chendu DIAO Pharmaceutical Group CO., LTD.

    lead INDUSTRY

Principal Investigators

  • Juan Li, Doctor · Gulou Hospital Affiliated to Nanjing Medical University, Jiangsu, China.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-18
Primary Completion
2024-08-03
Completion
2024-08-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534346 on ClinicalTrials.gov