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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Biological: Actrapid; Biological: Wosulin R

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719108

WosulinR/PK-PD/HV/EMEA/2008/v2

Details and patient eligibility

About

The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.

Full description

The purpose of this study is the comparative evaluation of the Pharmacodynamics and Pharmacokinetics of two recombinant regular human insulin injections administered intravenously in healthy volunteers under the conditions of euglycemic clamp.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subject
2. Age between 18 and 45 years (both inclusive)
3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
4. Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 (both inclusive)
5. Non-smoker, defined as no nicotine consumption for at least one year.
6. Signed and dated informed consent obtained before any trial-related activities.

Exclusion criteria

1. Previous participation in this trial or other clinical trials within the last 3 months.
2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator.
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 (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
6. History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening.
7. Positive test for hepatitis B or C or HIV positive at screening or in the past.
8. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
9. Use of any insulin product in the past.
10. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen will be permitted.
11. Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks.
12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
13. Known or suspected allergy to trial products or related products.
14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Wosulin R

Experimental group

Description:

Wosulin R, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml

Treatment:

Biological: Wosulin R

Actrapid

Active Comparator group

Description:

Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml

Treatment:

Biological: Actrapid