NCT06534346

The Food Effect on Pharmacokinetics of DA-302168S

A Randomized, Open, Single-dose, Two-cycle, Two-sequence, Cross-over Design Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profile of a Single Oral DA-302168S Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study plans to enroll 16 participants. Qualified subjects will be randomly assigned to one of two dosing sequences (The first group will receive DA-302168S tablets on an fasting condition, followed by administration after high-fat meals. The second group adopts the opposite administration methods) in a 1:1 ratio. Each administration sequence consists of two cycles, with one administration per cycle and a 5-day washout period between each administration.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-18
• Primary completion: 2024-08-03
• Completion: 2024-08-03
• First posted: 2024-08-02
• Last updated: 2025-04-16

Locations

1 site across 1 country: China