CTRI/2020/12/030079招募中1 期
A double-blind, randomized, single-center, two treatment, four period, two sequence, replicate crossover, euglycemic clamp study to demonstrate equivalence in the Pharmacokinetic and Pharmacodynamic properties of Insulin Glargine injection 100IU/mL of Stelis Biopharma and LANTUS® (Insulin Glargine injection 100 IU/mL of Sanofi Aventis) in healthy, adult, human subjects under fasting condition. - Nil
Stelis Biopharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy adult human (both male and female) subjects aged between 21 to 55 years (both inclusive).
- •2. Subjects have BMI between 18.50 and 24.90 kg/m2 (both inclusive) with minimum of 55 kg weight.
- •3. Subject with Hemoglobin level >=12.0 G%, Plasma glucose (FBG)75-100 mg/dl. HbA1c <= 5.5.
- •4. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range
- •5. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •6. Subjects having clinically acceptable chest X-Ray (PA view) whose XRay was taken not more than 6 months prior to the dosing of Period 01. If report of X-ray done within last 6 months is not available / Volunteer
- •having significant past history related to respiratory disease or clinical research physician / investigator found abnormal observations (crepts,rhonchi, wheezing etc.) on auscultation in respiratory system
- •examination then Chest X-Ray (PA view) will be done during screening.
- •7. Subjects having negative urine screen for drugs of abuse (including amphetamine, barbiturate, benzodiazepines, marijuana, cocaine, and morphine.
- •8. Subjects having negative breath alcohol test.
- •9. Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •10. Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study until 30 days after the last dose of the study medication as judged by the investigator(s), such as Condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during the study conduct.
- •11. Subjects having negative Urine Pregnancy test at screening and Serum β-hCG (pregnancy test) at admission of Period 01 (only for female subjects).
- •12. For Female Subjects: Female 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 intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam.
- •Â· Postmenopausal for at least 01 year, if less than 1 year, then following acceptable contraceptive measures as mentioned above or
- •Â· Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •1. Hypersensitivity to exogenous insulin or any component of the product or
- •related class of the drugs.
- •2. History or presence of significant cardiovascular, pulmonary, hepatic,
- •renal, gastrointestinal, endocrine, immunological, urogenital,
- •dermatological, neurological or psychiatric disease or disorder.
- •3. Use of any treatment which could bring about induction or inhibition of
- •hepatic microsomal enzyme system within 30 days prior to dosing of
- •period 01.
- •4. History of hyperglycaemia (symptoms include nausea, vomiting,
- •drowsiness, flushed dry skin, dry mouth, increased frequency of
- •urination, thirst and loss of appetite as well as acetone breath)
- •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 presence of significant alcoholism or drug abuse in the past
- •8. History or presence of smoking (more than 10 cigarettes or beedis/week)
- •9. Having history of significant urticaria or other allergic reactions.
- •10. History or presence of significant gastric and/or duodenal ulceration,
- •thyroid disease, adrenal dysfunction, organic intracranial lesion such as
- •pituitary tumor or cancer.
- •11. Difficulty with donating blood.
- •12. Use of any prescribed medication or OTC medications during last 30
- •days prior to dosing of period 01 [these include thiazolidinediones, oral
- •hypoglycaemic agents, monoamine oxidase inhibitors, non-selective
- •betaadrenergic blocking agents, angiotensin converting enzyme
- •inhibitors, salicylates, anabolic steroids (except danazol and
- •oxymetholone), alpha-adrenergic blocking agents, quinine, quinidine,
- •sulphonamides, thiazides, glucocorticoids, thyroid hormones,
- •sympathomimetics, growth hormone, diazoxide, asparaginase, nicotinic
- •acid, oxymetholone, danazol, beta blockers, octreotide and lanreotide].
- •13. Major illness within past 3 months.
- •14. Volunteer who have donated blood (1 unit) or participation in a drug
- •research study within past 90 days prior to the first dose of the study
- •15. Consumption of grapefruit or its products within 72 hours prior to dosing.
- •16. Consumption of xanthine-containing foods or beverages and alcohol or
- •alcoholic products and caffeine within 48 hours prior to dosing.
- •17. Positive screening test for any one or more: HIV, Hepatitis A, B and
- •Hepatitis C or VDRL.
- •18. History or presence of significant recent trauma.
- •19. History or presence of significant easy bruising or bleeding
- •20. Subjects who have been on an abnormal diet (for whatever reason) during
- •the four weeks preceding the study.
- •21. Female subjects who are currently breast feeding.
- •22. Female subjects of child bearing potential using any oral/injectable
- •hormones/hormonal derivative products to prevent pregnancy.
- •23. Pregnant females
研究者
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