Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT04184492
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2019-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Pharmacokinetics and Pharmacodynamics of GP-40081 to NovoMix® 30 Penfill® in Healthy Subjects
Sponsor:
Geropharm
Organization:
Study Overview
Official Title:
A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of GP-40081 (LLC "GEROPHARM", Russia) Versus NovoMix® 30 Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique
Status:
COMPLETED
Status Verified Date:
2019-11
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:
Pharmacokinetics and pharmacodynamics study of 2 formulations of biphasic insulin aspart 30 (GP-40081 GEROPHARM vers. NovoMix® 30 Penfill® Novo Nordisk)
Detailed Description:
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of GP-40081 (LLC "GEROPHARM", Russia) versus NovoMix® 30 Penfill® (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
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?: