None listed
Conditions
Interventions
Intervention1: Insulin Glargine: A single dose of 0.4 IU/Kg, subcutaneously
Control Intervention1: Insulin glargine of innovator: A single dose of 0.4 IU/Kg, subcutaneously
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy human subjects between 18-45 years of age (including both) and weight >= 50 Kg (BMI 18.5 to 24.9kg/m²). 2. Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12- lead ECG and Chest X-Ray (postero-anterior view). 3. Values within normal ranges for laboratory parameters upon evaluation by the Investigator or Physician Subjects able to communicate effectively. 5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 6. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 48.00 hours before admission till the last blood sample in each Period. 7. Subjects without any evidence of impaired glucose tolerance in 2 hours oral glucose tolerance test.
Exclusion criteria
Exclusion criteria: 1. Volunteers having contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or related class of drugs and any of its ingredients will be excluded from the study. 2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. 3. History of diabetic ketoacidosis 4. History of hypoglycaemia (Symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting) 5. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). 6. Any known enzyme inducing or inhibiting drug taken within 30 days before the study. 7. Participation in a drug research study within 90 days prior to dosing of this study. 8. Blood loss or whole blood donation within 90 days prior to drug administration. 9. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day). 10. History of addiction to any recreational drug or drug dependence. 11. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g. fasting due to religious reasons. 12. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period. 13. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period. 14. Positive results for alcohol breathe analysis during the study check-in of each period. 15. History of pre-existing bleeding disorder. 16. Difficulty with donating blood. 17. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. 18. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 19. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 20. Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing. 21. History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INS-AUC(0-24h), Cmax, Tmax.Timepoint: 0-24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| GIR-AUC(0-24h), GIRmax, TGIRmaxTimepoint: 0-24 hrs | — |
Countries
India
Contacts
Public ContactDrHemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed