NCT06536036

Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

A Single Center, Randomized, Open Label, Single Dose, Two-Period, Crossover Phase I Study to Evaluate the Effect of Food (high-fat/standard Meal) on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open label, single dose, two-period, crossover trial phase I study. The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.

Detailed description

Part A High Fat Meal Test: Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 1 and Group 2) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or high-fat diet conditions. Part B Standard Meal Test (optional part): Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 3 and Group 4) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or standard meal conditions.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	SIM0270	Use according to the prescribed protocol

Timeline

• Start date: 2024-07-23
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2024-08-02
• Last updated: 2024-12-02

Locations

1 site across 1 country: China