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Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects | Clinical Trials | Clareo Health

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Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

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

NCT00772265•Wockhardt

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male or female subject.
•Age more than 18 and less than 45 years.
•Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
•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 30 days.
•Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
•Clinically significant abnormal haematology 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 in the past five years and/or any positive test for drugs of abuse at screening.
•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.
+5 more criteria

Locations (1)

Profil Institute for clinical Research

Chula Vista, California, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

April 1, 2011

Last Updated

December 27, 2012

Enrollment

ACTUAL participants

Conditions

Diabetes

Interventions

Wosulin N

BIOLOGICAL

Novolin N

BIOLOGICAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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