Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 7:52 AM
Study NCT ID:
NCT05363592
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate Bioequivalence After Co-administration of ALO 12.5 mg and MET XR 500 mg or Administration of CT-L01 12.5/500 mg in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-01
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 is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
Detailed Description:
None
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?: