Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
NCT ID: NCT01358435
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2011-01-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Wosulin 70/30
Wosulin 70N /30R is a recombinant Human Insulin with 30 % Regular Insulin Human Neutral and 70% Isophane Insulin, 600 nmol/ml, 100 IU/ml.
30% Regular Insulin Human Neutral and 70%Isophane Insulin
Total Dose per subject is 0.4 IU/Kg given subcutaneously.
Novolin 70/30
Novolin 70/30 is a Recombinant Human Insulin with 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection
Novolin 70/30
Total Dose per subject is 0.4IU/Kg given Subcutaneously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
30% Regular Insulin Human Neutral and 70%Isophane Insulin
Total Dose per subject is 0.4 IU/Kg given subcutaneously.
Novolin 70/30
Total Dose per subject is 0.4IU/Kg given Subcutaneously.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 and ≤ 45 years.
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 27.0 kg/m2, 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. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.).
Exclusion Criteria
2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
3. Clinically significant abnormal haematology 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) or fasting glucose at screening outside the range of 70-99 mg/dl 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 in the past five years.
7. Any positive test for drugs of abuse and /or alcohol at screening.
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. Treatment with any insulin product in the past.
11. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen 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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wockhardt
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Marcus Hompesch
Role: STUDY_DIRECTOR
Profil Institute for Clinical Research, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Profil Institute for Clinical Research
Chula Vista, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Wosulin 7030/PK-PD/HV/FDA/10/3
Identifier Type: -
Identifier Source: org_study_id