None listed
Conditions
Interventions
Intervention1: Formulation A (Test Drug): Wosulin 30R /70N (600 nmol/ml, 100 IU/ml), vials 10.0 ml.: Single dose
SC route of administration
Control Intervention1: Formulation B ( Reference): Insulin Novolin® 70/30 (600 nmol/ml, 100 IU/ml), vials 10.0 ml: Single dose
SC route of administeration
Control Intervention2: Nil: nil
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Considered generally healthy upon completion of medical history, physical examination X-ray chest (PA view), ECG and biochemical investigations as judged by the Investigator. 2. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive. 3. Non-smoker, defined as no nicotine consumption for last six months. 4. Subjects who agreed for verbal and written consent to audio-visual recording of the discussion of consent process and agreed to provide the signed and dated informed consent before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.). 5. Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
Exclusion criteria
Exclusion criteria: 1. Previous participation in this trial or other clinical trials within the last 90 days. 2. 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) 3. History/presence of disorder related to CVS, CNS, Respiratory tract, GIT, Endocrinology, Haematology, Immunological or any other systemic disorder including any serious systemic infectious disease, as judged by the Investigator. 4. 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, gross anaemia (or subject with haemoglobin level 12 gm/dl at screening) or hemoglobinopathy will not be eligible to participate in the trial. 5. History of alcohol or drug abuse in the past five years. 6. Any positive test for drugs of abuse and /or alcohol at screening. 7. Hepatitis B or C or HIV or VDRL positive. 8. Use of prescription drugs within 3 weeks prior to screening. 9. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to screening. 10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation. 11. Blood donation of more than 500 ml within the last 12 weeks. 12. Unwilling to stay in the clinical unit for the required duration or consume the standard meal to be provided as per the protocol. 13. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 14. Known or suspected allergy to trial product or related products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: AUC0-24 and Cmax PD: AUCGIR0-24, and GIR max Timepoint: 24 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| PK endpoints: AUC04 h, AUC0 6h, AUC0 12h, AUC6 12h, AUC6 24h, AUC12 24h, AUC0, tmax, t½ and elimination rate constant (ï?¬z) PD endpoints: AUCGIR0 4h, AUCGIR0 6h, AUCGIR0 12h,, AUCGIR6 12h, AUCGIR6 24h, AUCGIR12 24h and tGIRmax Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability. Timepoint: Various time points during the clamp phase | — |
Countries
India
Contacts
Public ContactShraddha Tawade
Nashik Biotech Clamp Unit
Outcome results
None listed