Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534346
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
The Food Effect on Pharmacokinetics of DA-302168S
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
ENROLLING_BY_INVITATION
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:
DA168
Brief 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 11 ratio Each administration sequence consists of two cycles with one administration per cycle and a 5-day washout period between each administration
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