A double blind, balanced, randomized, two-treatment, two-sequence, four-period, single-dose,crossover, full replicate pharmacokinetic and pharmacodynamic bioequivalence study ofVB70G (Insulin Glargine injection) 100 IU/mL of Virchow Biotech, Hyderabad, India andLANTUSÂ® (Insulin Glargine injection) 100 IU/mL of Sanofi-Aventis, in healthy adult, human malesubjects using Euglycemic clamp technique under fasting conditions.

Virchow Biotech Private Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2023年5月29日

试验速览

阶段: 未知
状态: 已完成
发起方: Virchow Biotech Private Limited
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Ba/be

入排标准

入选标准

•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
•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.

排除标准

•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.

研究者

发起方

Virchow Biotech Private Limited

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