Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06304805
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TGRX-326 Pharmacokinetic Food Effect Bioavailability Study
Sponsor:
Shenzhen TargetRx, Inc.
Organization:
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:
2025-05
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:
False
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?:
False
Is an FDA AA801 Violation?: