Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492226
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INSA US-NovoLog and EU-NovoRapid
Sponsor:
Xentria Inc
Organization:
Xentria Inc
Study Overview
Official Title:
A Single-center Single-dose Double-blind Randomized Three-period Three-treatment Six-sequence Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INSA US-NovoLog and EU-NovoRapid Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Single-dose double-blind randomized three-period three-treatment six-sequence crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INSA US-NovoLog and EU-NovoRapid
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-INSA US-NovoLog and EU-NovoRapid using the euglycemic clamp technique in healthy male adult volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None