Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.
NCT ID: NCT00719108
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2008-07-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Wosulin R
Wosulin R, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml
Wosulin R
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Actrapid
Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml
Actrapid
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Interventions
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Wosulin R
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Actrapid
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Wockhardt
INDUSTRY
Responsible Party
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Principal Investigators
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Marcus Hompesch, MD
Role: STUDY_DIRECTOR
Profil Institute of Clinical Research
Locations
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Profil Institute for Clinical Research Inc.
Chula Vista, California, United States
Countries
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Other Identifiers
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WosulinR/PK-PD/HV/EMEA/2008/v2
Identifier Type: -
Identifier Source: org_study_id