Trials / Completed
CompletedNCT03606018
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mix 25 to Humalog® Mix 25 in Healthy Subjects
A Randomized Duble Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Lispro Mix 25 (LLC "GEROPHARM", Russia) Versus Humalog® Mix 25 (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Geropharm · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro mix 25 (Insulin Lispro Mix 25 GEROPHARM vers. Humalog® Mix 25 Eli Lilly)
Detailed description
A randomized duble blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Lispro Mix 25 (LLC "GEROPHARM", Russia) versus Humalog® Mix 25 (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin Lispro Mix 25 | insulin lispro biphasic in doses 0.4 ME/kg |
| DRUG | Humalog® Mix 25 | insulin lispro biphasic in doses 0.4 ME/kg |
Timeline
- Start date
- 2017-04-12
- Primary completion
- 2017-07-13
- Completion
- 2017-07-13
- First posted
- 2018-07-30
- Last updated
- 2018-07-31
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT03606018. Inclusion in this directory is not an endorsement.