Clincosm LogoSign in Get a demo

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

Sponsor
Wockhardt (Industry)
Overall Status
Completed
CT.gov ID
NCT00719108
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
2
Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Wosulin R
  • Biological: Actrapid
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial to Test Bioequivalence Between Two Recombinant Human Soluble Insulins - Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Wosulin R

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

Biological: Wosulin R
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Active Comparator: Actrapid

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

Biological: Actrapid
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

Outcome Measures

Primary Outcome Measures

  1. The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS) [Visit 2 and 3]

Secondary Outcome Measures

  1. PD Endpoints: Area under the GIR-time curve from 0 to 7 hours, GlR at steady state. PK Endpoints: AUCINS-SS, AUCINS0-7h, CLtot, VSS, t1/2 ,Terminal rate constant Safety Endpoints: AE, Lab assessments, Vital signs, Phy Exam, ECG & Hypoglycemia. [Visit 2 , 3 and 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Profil Institute for Clinical Research Inc. Chula Vista California United States 91911

Sponsors and Collaborators

  • Wockhardt

Investigators

  • Study Director: Marcus Hompesch, MD, Profil Institute of Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wockhardt
ClinicalTrials.gov Identifier:
NCT00719108
Other Study ID Numbers:
  • WosulinR/PK-PD/HV/EMEA/2008/v2
First Posted:
Jul 21, 2008
Last Update Posted:
Dec 27, 2012
Last Verified:
Dec 1, 2012
Keywords provided by Wockhardt
Diabetes, Healthy Volunteers
Additional relevant MeSH terms:
Insulin
Insulin, Globin Zinc

Study Results

No Results Posted as of Dec 27, 2012