Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 7:10 PM
Study NCT ID:
NCT05009368
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2021-12
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 two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0901 and CTL0902 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: