PHARMACOKINETIC, PHARMACODYNAMIC BIOEQUIVALENCE STUDY ON VB70G(INSULIN GLARGINE INJECTION) 100 IU/ML - FASTING
- Registration Number
- CTRI/2022/08/044806
- Lead Sponsor
- Virchow Biotech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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 <5.7%
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary PK Parameters <br/ ><br>INS-AUC0-t, INS-AUC0-inf, and Cmax <br/ ><br> <br/ ><br>Primary PD Parameters <br/ ><br>GIR-AUC0-24 and GIRmaxTimepoint: 0-24 hrs
- Secondary Outcome Measures
Name Time Method Secondary PK parameters: <br/ ><br>Tmax , t1/2 and Kel <br/ ><br> <br/ ><br>Secondary PD Parameters: <br/ ><br>TGIRmax. <br/ ><br>Timepoint: 0-24 hrs