Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-13
Brief Title:
A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects
Sponsor:
Shouyao Holdings Beijing Co LTD
Organization:
Shouyao Holdings Beijing Co LTD
Study Overview
Official Title:
A Randomized Open-label Single-dose Two-period Two-treatment Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of SY-5007 Tablets in Chinese Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-center randomized open-label single-dose two-period two-treatment crossover trial aimed at evaluating the pharmacokinetic PK profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China
Detailed Description:
The study consists of two parts a pilot study and a formal study The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal high-fat meal for Period 1 and on an empty stomach for Period 2 with observation and PK blood sample collection
The formal study plans to enroll 24 healthy subjects divided into Groups A and B each with 12 subjects receiving a dose of 160 mg Group A will receive the drug on an empty stomach for Period 1 followed by administration after a meal high-fat meal for Period 2 while Group B will follow the reverse sequence Both groups will adopt a two-period two-treatment crossover design with a washout period of 7 days If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007 subsequent trial protocols may be adjusted
The formal study plans to enroll 24 healthy subjects divided into Groups A and B each with 12 subjects receiving a dose of 160 mg Group A will receive the drug on an empty stomach for Period 1 followed by administration after a meal high-fat meal for Period 2 while Group B will follow the reverse sequence Both groups will adopt a two-period two-treatment crossover design with a washout period of 7 days If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007 subsequent trial protocols may be adjusted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None