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

Wockhardt2 sites in 1 country25 target enrollmentJanuary 2008

ConditionsDiabetes Mellitus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Wockhardt
Enrollment: 25
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

February 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Wockhardt

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.(Visit 2, 3 and 4)