Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304805
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-05
Brief Title:
TGRX-326 Phase III Pharmacokinetic Study
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
A Randomized Open-label Single-dose 3-cycle 6-sequence Crossover Study Evaluating Food Effect on Pharmacokinetic Profiles of TGRX-326 in Chinese Healthy Subjects and Effect of Drug Specification on Bioavailability in Human
Status:
COMPLETED
Status Verified Date:
2024-04
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:
A study evaluating the effects of food intake on the pharmacokinetic PK profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326 a drug indicated for non-small cell lung cancer treatment
Detailed Description:
This study is designed as single-center randomized open-label 3-cycle 6-sequence and crossover design to evaluate 1 food effect on PK profile of TGRX-326 2 effect of different specifications of TGRX-326 on human bioavailability Safety for food effect on TGRX-326 and safety for different TGRX-326 specifications were also evaluated
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