Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.

NCT ID: NCT00596063

Last Updated: 2012-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-02-29

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.

Conditions

Diabetes Mellitus

Keywords

pharmacokinetics; pharmacodynamics; recombinant human insulin; healthy volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Wosulin R

Regular insulin for subcutaneous injection (recombinant human insulin), 600nmol, 100 IU

Group Type: EXPERIMENTAL

Wosulin R

Intervention Type: BIOLOGICAL

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Novolin R

Regular insulin for injection (recombinant human insulin)

Group Type: ACTIVE_COMPARATOR

Novolin R

Intervention Type: BIOLOGICAL

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Interventions

Wosulin R

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Intervention Type: BIOLOGICAL

Novolin R

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female subject.

2. Age ≥ 18 and ≤ 45 years.

3. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.

4. Non-smoker, defined as no nicotine consumption for at least one year.

5. 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

1. Previous participation in this trial or other clinical trials within the last 3 months.

2. 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).

3. 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.

4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.

5. 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.

6. History of alcohol or drug abuse.

7. Any positive reaction of drugs of abuse.

8. Hepatitis B or C or HIV positive.

9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.

10. Use of any insulin product for therapeutic purposes in the past.

11. 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.

12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

13. Blood donation of more than 500 ml within the last 12 weeks.

14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

15. Known or suspected allergy to trial product or related products.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Morrow, M.D

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research, Inc.

Locations

Profil Institute for Clinical Research Inc.

Chula Vista, California, United States

Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Countries

United States

Other Identifiers

Not yet created

Identifier Type: -

Identifier Source: secondary_id

Wosulin R/PK-PD/HV/FDA/07/v1

Identifier Type: -

Identifier Source: org_study_id