Diabetes
Conditions
Keywords
Bioequivalence, pharmacokinetic, Pharmacodynamic, Isophane insulin
Brief summary
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
Detailed description
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
Interventions
BIOLOGICALWosulin N
Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
BIOLOGICALNovolin N
Total dose per subject will be 0.4 IU/Kg given Subcutaneously.
Sponsors
Wockhardt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subject. * Age more than 18 and less than 45 years. * Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive. * Non-smoker, defined as no nicotine consumption for at least one year. * 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
* Previous participation in this trial or other clinical trials within the last 30 days. * 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). * 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) will not be allowed to enter the trial. * Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator. * 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. * History of alcohol or drug abuse in the past five years and/or any positive test for drugs of abuse at screening. * Any positive reaction of drugs of abuse. * Hepatitis B or C or HIV positive. * Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. * Use of any insulin product for therapeutic purposes in the past. * Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of acetaminophen is permitted. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. * Blood donation of more than 500 ml within the last 12 weeks. * History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. * Known or suspected allergy to trial product or related products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean AUC0-24h and Cmax | Visit 2 and 3 |
Secondary
| Measure | Time frame |
|---|---|
| PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam. | Visit 2,3 and 4 |
Countries
United States
Outcome results
None listed