Trials / Completed
CompletedNCT04184492
A Study to Compare Pharmacokinetics and Pharmacodynamics of GP-40081 to NovoMix® 30 Penfill® in Healthy Subjects
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GP-40081 | biphasic insulin aspart 30 in doses 0.4 IU/kg |
| DRUG | NovoMix® 30 Penfill® | biphasic insulin aspart 30 in doses 0.4 IU/kg |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
- First posted
- 2019-12-03
- Last updated
- 2019-12-03
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04184492. Inclusion in this directory is not an endorsement.