Trials / Completed
CompletedNCT00752180
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics
A Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.
Detailed description
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well as assesses safety and local tolerability of the two insulin preparations in type 1 diabetics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Wosulin R | Total dose per subject will be 0.3 IU/Kg given Subcutaneously. |
| BIOLOGICAL | Actrapid | Total dose per subject will be 0.3 IU/kg given Subcutaneously. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-03-01
- Completion
- 2009-04-01
- First posted
- 2008-09-15
- Last updated
- 2012-12-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00752180. Inclusion in this directory is not an endorsement.