Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wockhardt |
---|---|
Information provided by: | Wockhardt |
ClinicalTrials.gov Identifier: | NCT00772265 |
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
Condition | Intervention | Phase |
---|---|---|
Diabetes |
Biological: Isophane insulin for inj. (Recomb Human insulin) (Wosulin N) Biological: Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N) |
Phase I |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment |
Official Title: | A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects |
Estimated Enrollment: | 56 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Wosulin N, Isophane insulin for injection (Recombinant Human Insulin)(100 IU/mL), cartridges 3.0 mL
|
Biological: Isophane insulin for inj. (Recomb Human insulin) (Wosulin N)
Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
|
2: Active Comparator
Novolin N, Isophane insulin for injection (Recominant Human Insulin)(100IU/ml),cartridges 3.0ml.
|
Biological: Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N)
Total dose per subject will be 0.4 IU/Kg given Subcutaneously.
|
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Alexa Kollmeier | 619.409.1264 | alexa.kollmeier@profil-research.com |
United States, California | |
Profil Institute for clinical Research | Recruiting |
chula vista, California, United States, 91911 | |
Principal Investigator: Dr. Alexa Kollmeier |
Study Chair: | Heidi Guthrie | Profil institute for clinical Research |
Responsible Party: | Wockhardt Limited ( Dr.R Jha ,Senior Vice-president - Clinical Research ) |
Study ID Numbers: | WosulinN/PK-PD/HV/FDA/08/v2d1 |
Study First Received: | October 14, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772265 |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence pharmacokinetic Pharmacodynamic Isophane insulin |
Diabetes Mellitus Healthy Insulin, Isophane Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |