Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
This study has been completed.
Sponsor:
Wockhardt
Information provided by:
Wockhardt
ClinicalTrials.gov Identifier:
NCT00596063
First received: January 7, 2008
Last updated: May 20, 2011
Last verified: May 2011
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Purpose
Detailed Description:
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 |
---|---|---|
Diabetes Mellitus |
Biological: Wockhardt's recombinant human insulin (Wosulin R) Biological: Novolin R |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Further study details as provided by Wockhardt:
Primary Outcome Measures:
- The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R [ Time Frame: Visit 2 & 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PK endpoints: AUC, tmax and t½ PD endpoints: AUC-GIR, GIRmax and tGIRmax Safety endpoints: AEs, haematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability. [ Time Frame: Visit 2, 3 and 4 ] [ Designated as safety issue: Yes ]
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 |
---|---|
Experimental: Wosulin R
Regular insulin for injection (recombinant human insulin)
|
Biological: Wockhardt's recombinant human insulin (Wosulin R)
Penfill cartridges; Single Dose, 0.2 IU/ kg
|
Active Comparator: Novolin R
Regular insulin for injection (recombinant human insulin)
|
Biological: Novolin R |
Detailed Description:
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.
Eligibility
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female subject.
- Age ≥ 18 and ≤ 45 years.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.).
Exclusion Criteria:
- Previous participation in this trial or other clinical trials within the last 3 months.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant).
- 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.
- Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- History of alcohol or drug abuse.
- Any positive reaction of drugs of abuse.
- Hepatitis B or C or HIV positive.
- Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
- Use of any insulin product for therapeutic purposes in the past.
- Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol is permitted.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- Blood donation of more than 500 ml within the last 12 weeks.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Known or suspected allergy to trial product or related products.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596063
Locations
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 |
Sponsors and Collaborators
Wockhardt
Investigators
Principal Investigator: | Linda Morrow, M.D | Profil Institute for Clinical Research, Inc. |
More Information
No publications provided
Keywords provided by Wockhardt:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Dr. R. Jha, Senior Vice President - Clinical Research, Wockhardt Limited |
ClinicalTrials.gov Identifier: | NCT00596063 History of Changes |
Other Study ID Numbers: | Wosulin R/PK-PD/HV/FDA/07/v1, Not yet created |
Study First Received: | January 7, 2008 |
Last Updated: | May 20, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wockhardt:
pharmacokinetics pharmacodynamics recombinant human insulin healthy volunteers |
Additional relevant MeSH terms:
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012