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Sponsored by: |
Wockhardt |
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Information provided by: | Wockhardt |
ClinicalTrials.gov Identifier: | NCT00596063 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Biological: Wockhardt's recombinant human insulin (Wosulin R) Biological: Novolin R |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment |
Official Title: | A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects |
Estimated Enrollment: | 25 |
Study Start Date: | January 2008 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Wosulin R: Experimental
Regular insulin for injection (recombinant human insulin)
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Biological: Wockhardt's recombinant human insulin (Wosulin R)
Penfill cartridges; Single Dose, 0.2 IU/ kg
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Novolin R: Active Comparator
Regular insulin for injection (recombinant human insulin)
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Biological: Novolin R |
A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator.
In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
United States, California | |
Profil Institute for Clinical Research Inc. | |
Chula Vista, California, United States, 91911 | |
Profil Institute for Clinical Research, Inc. | |
Chula Vista, California, United States, 91911 |
Principal Investigator: | Linda Morrow, M.D | Profil Institute for Clinical Research, Inc. |
Responsible Party: | Wockhardt Limited ( Dr. R. Jha, Senior Vice President - Clinical Research ) |
Study ID Numbers: | Wosulin R/PK-PD/HV/FDA/07/v1, Not yet created |
Study First Received: | January 7, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00596063 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pharmacokinetics pharmacodynamics recombinant human insulin healthy volunteers |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Healthy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |