CTRI/2022/12/048456已完成未知
An open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,cross-over, bioequivalence study of Liraglutide 0.6 mg Injection (6 mg/mL) (Test) of VirchowBiotech Private Limited, India and Victoza® (Liraglutide) injection in pre-filled pen 0.6 mg (6 mg/mL) of Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark in normal, healthy adult,human subjects under fasting conditions. - Nil
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 32
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)
- •2. Subjects able to communicate effectively.
- •3. Truly voluntarily participation
- •4. Subjects willing to take injection at selected site.
- •5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •6. Body mass index in the range of 18.5 to 29.9kg/m² (weight should be >= 50 Kg)
- •7. Normal 12-lead ECG
- •8. Normal chest X-ray
- •9. Normal laboratory parameters
- •10. Subject who had HbA1c levels <6.5%
- •11. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL
- •12. 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.
- •13. Female subjects
- •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •1. Volunteers having contraindication or hypersensitivity (e.g., anaphylaxis) to liraglutide or related class of drugs and any of its ingredients
- •2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- •3. History or presence of diabetes, migraine, hypertension, cardiovascular, pulmonary, 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.
- •4. History or presence of significant systemic diseases, seizures, psychiatric disorders, neurological disorders.
- •5. History of diabetic ketoacidosis
- •6. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting)
- •7. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •8. Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
- •9. Participation in a drug research study within 90 days prior to dosing of this study.
- •10. Blood loss or whole blood donation within 90 days prior to drug administration.
- •11. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
- •12. History of addiction to any recreational drug or drug dependence.
- •13. 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.
- •14. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each period.
- •15. Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
- •16. Positive results for alcohol consumption during the admission of each study period.
- •17. Females with positive results on serum pregnancy test.
- •18. History of pre-existing bleeding disorder.
- •19. Difficulty with donating blood.
- •20. Difficulty in swallowing oral solid medicinal products.
- •21. Blood pressure on the day of admission of each study period
- •a. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •22. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
- •23. 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.
- •24. 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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