Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627478
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine G United States US-Lantus and European Union EU-Lantus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-dose Double-blind Randomized Three-period Three-treatment Six-sequence Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INSG US-Lantus and EU-Lantus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Single-dose double-blind randomized three-period three-treatment six-sequence crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine G United States US-Lantus and European Union EU-Lantus
Detailed Description:
A single center single-dose double-blind randomized three-period three-treatment six-sequence crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INSG US-Lantus and EU-Lantus using the euglycemic clamp technique in healthy male adult volunteers
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