Trials / Completed
CompletedNCT04184466
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects
A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Aspart (LLC "GEROPHARM", Russia) Versus NovoRapid® Penfill® (Novo Nordisk) in Healthy Subjects Using the Euglycemic Clamp Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin aspart (Insulin Aspart GEROPHARM vers. NovoRapid® Penfill® Novo Nordisk)
Detailed description
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Aspart (LLC "GEROPHARM", Russia) versus NovoRapid® Penfill® (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin Aspart | insulin aspart in doses 0.3 IU/kg |
| DRUG | NovoRapid® Penfill® | insulin aspart in doses 0.3 IU/kg |
Timeline
- Start date
- 2018-10-18
- Primary completion
- 2018-12-19
- Completion
- 2018-12-19
- First posted
- 2019-12-03
- Last updated
- 2019-12-03
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04184466. Inclusion in this directory is not an endorsement.