Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wockhardt |
---|---|
Information provided by: | Wockhardt |
ClinicalTrials.gov Identifier: | NCT00752180 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes |
Biological: Regular insulin for inj. (Recomb.Humain Insulin) (Wosulin R) Biological: Regular insulin for inj.(Recomb.Human Insulin)(Actrapid) |
Phase I |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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 |
Estimated Enrollment: | 28 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Wosulin R,Regular insulin for injection(Recombinant Human Insulin)(600 nmol/ml, 100IU/ml)in vials 10.0 ml.
|
Biological: Regular insulin for inj. (Recomb.Humain Insulin) (Wosulin R)
Total dose per subject will be 0.3 IU/Kg given Subcutaneously.
|
B: Active Comparator
Actrapid,Regular insulin for injection (Recombinant Human Insulin) (600nmol/ml,100IU/ml)in vials 10.0 ml.
|
Biological: Regular insulin for inj.(Recomb.Human Insulin)(Actrapid)
Total dose per subject will be 0.3 IU/kg given Subcutaneously.
|
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr.Linda Morrow, MD | 619.409.1268 | linda.morrow@profil-research.com |
United States, California | |
Profil Institute for Clinical Research | Recruiting |
Chula Vista, California, United States, 91911 | |
Principal Investigator: Dr.Linda Morrow, MD |
Study Director: | Till Schroer | Profil Institute for Clinical Research |
Responsible Party: | Wockhardt Limited ( Dr.R Jha ,Senior Vice-president - Clinical Research ) |
Study ID Numbers: | WosulinR/PK-PD/type1/EMEA/2008 |
Study First Received: | September 12, 2008 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00752180 |
Health Authority: | United States: Food and Drug Administration |
pharmacokinetics pharmacodynamics type 1 diabetics recombinant human insulin |
Diabetes Mellitus Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |