Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536036
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Center Randomized Open Label Single Dose Two-Period Crossover Phase I Study to Evaluate the Effect of Food High-fatStandard Meal on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 pharmacokineticsPK of SIM0270 after oral administration under fasted standard meal or high-fat diet conditions
The purpose of this study is to evaluate the food effect on the pharmacokineticsPK 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 11 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 11 ratio for a two-period crossover trial The subjects administered a single dose of SIM0270 under fasted or standard meal conditions
Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups Group 1 and Group 2 in a 11 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 11 ratio for a two-period crossover trial The subjects administered a single dose of SIM0270 under fasted or standard meal conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None