Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
NCT00596063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2012-12-27
Summary
The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.
Conditions
Interventions
- BIOLOGICAL
-
Wosulin R
Penfill cartridges; Single Dose, 0.2 IU/ kg;
- BIOLOGICAL
-
Novolin R
Penfill cartridges; Single Dose, 0.2 IU/ kg;
Sponsors & Collaborators
-
Wockhardt
lead INDUSTRY
Principal Investigators
-
Linda Morrow, M.D · Profil Institute for Clinical Research, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2008-02-29
- Completion
- 2008-02-29
Countries
- United States
Study Locations
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