None listed
Conditions
Interventions
Intervention1: Wosulin® N, (100 IU/mL) 3 ml cartridges of Wockhardt Ltd.: 0.4 IU/kg body weight of study drug will be administered subcutaneously.
Control Intervention1: Humulin娕? N, (100 U/mL) 3 m
Sponsors
Wockhardt Bio AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged between 18 and 45 years both inclusive. 2. Subjects weight within the normal range according to normal values for the Body Mass Index 18.5 to 27.0 kg/m2, both inclusive with minimum of 50 kg weight. 3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. 4. Subjects having clinically acceptable 12 lead electrocardiogram. 5. Subjects having clinically acceptable chest X Ray PA view. 6. Non smoker, defined as no nicotine consumption for last six months. 7. Have a negative urine screen for drugs of abuse including amphetamine, barbiturate, benzodiazepines, marijuana, cocaine, and morphine. 8. Have a negative alcohol breath analysis. 9. Subjects willing to adhere to the protocol requirements and are 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. 10. Subjects with normal results of 2 hours Oral Glucose Tolerance Test performed at screening. 11. Subject agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from screening till 90 days following the last administration of the study drug and to not donate sperm during this period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to Insulin or related class of drugs. 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. Subjects with hemoglobin levels 4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. 5. History or presence of significant alcoholism or drug abuse in the past one year. 6. HbA1c values at screening >= 5.7% 7. Subjects who is Hepatitis B or C or HIV or RPR positive. 8. History or presence of significant asthma, urticaria or other allergic reactions. 9. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 10. Known presence of cancer. 11. Family history of diabetes mellitus. 12. Difficulty with donating blood. 13. Major illness during past 3 months. 14. Subject who have donated blood 350 mL or more within 90 days. 15. Subjects who have received any investigational drug within 90 days from screening visit. 16. Use of prescription and non prescription drugs, except routine vitamins, within 2 weeks prior to screening till study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: AUC0-24 and CmaxTimepoint: up to 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, AUC12-24h, AUC0-inf, tmax, t½ and terminal plasma insulin elimination half-life PD endpoints: AUCGIR, 0-24 and GIRmax, AUCGIR,0-4h, AUCGIR,0-6h, AUCGIR,0-12h, AUCGIR,6-12h, AUCGIR,6-24h, AUCGIR,12-24h and tGIRmax Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability.Timepoint: up to 24.00 hours | — |
Countries
India
Contacts
Public ContactDr Mushtaque Mastim
Wockhardt Limited
Outcome results
None listed