None listed
Conditions
Interventions
Intervention1: VB70G: (Insulin Glargine injection) 100 IU/mL of Virchow Biotech
single dose 0.4IU/Kg per period
Control Intervention1: LANTUS: (Insulin Glargine injection) 100 IU/mL of Sanofi-Aventis
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects between 18-45 years of age (including both) and weight >= 50 Kg(BMI 18.5-24.9 Kg/m2 2. Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluation, 12-lead ECG and chest X-ray (postero-anterior view). 3. HbA1c levels 4. Normal range for OGTT 5. Values within normal ranges of laboratory parameters upon evaluation by the investigator or physician for any of the following tests: Note: Normal ranges for all laboratory parameters will be specific to diagnostic laboratory. For hemoglobin range, an acceptable limit of up to 5% to the lower limit will be considered as normal at pre study. 6. Subjects able to communicate effectively. 7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 8. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 72.00 hours before admission till the last blood sample in each period. 9. Subjects without any evidence of impaired glucose tolerance in 2 hours oral glucose tolerance test.
Exclusion criteria
Exclusion criteria: 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 14 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 admission of each period. 13. Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study admission of each period. 14. Positive results for alcohol consumption during the study admission 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. No prescription drugs are allowed within 14 days or at least 5 half lives of the compound whichever period is longer prior to study admission. No herbal medicines and any OTC medications including vitamins are allowed within 14 days or at least 5 half lives of the compound whichever period is longer prior to study admission During the course of the study, only drugs administered by ADVITY study personnel and medication necessary to counteract adverse events will be permitted. 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 |
|---|---|
| Primary PK Parameters INS-AUC0-t, INS-AUC0-inf, and Cmax Primary PD Parameters GIR-AUC0-24 and GIRmaxTimepoint: 0-24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary PK parameters: Tmax , t1/2 and Kel Secondary PD Parameters: TGIRmax. Timepoint: 0-24 hrs | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Managing Director
Outcome results
None listed