CTRI/2020/05/025383已完成1 期
An open label, randomized, two-treatment, two-sequence, four-period, single-dose, full replicate crossover bioequivalence study of VB70G (Insulin Glargine injection) 100 IU/mL of Virchow Biotech, Hyderabad, India and LANTUS® (Insulin Glargine injection) 100 IU/mL of Sanofi-Aventis, India in healthy male, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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
- •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.
排除标准
- •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.
研究者
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