CTRI/2020/09/027956已完成1 期
An open label, randomized, two-treatment, two-sequence, four-period, single-dose, full replicate crossover bioequivalence study of GEN1501 (Insulin Glargine Injection) 100 U/mL of GeneSys Biologics Pvt. Ltd., Hyderabad, India and LANTUS�® (Insulin Glargine Injection) 100 U/mL of Sanofi-Aventis, in healthy male, adult, human subjects under fasting conditions. - GEN1501
试验速览
- 阶段
- 1 期
- 状态
- 已完成
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 human subjects between 18-45 years of age (including both) and weight ââ?°Â¥ 50 Kg (BMI 18.5 to 24.9 kg/mÃ?²).
- •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. HbA1c levels <5.7%
- •4. Normal range for OGTT
- •5. Values within normal ranges for laboratory parameters upon evaluation by the Investigator or Physician.
- •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 48:00 hours before admission till the last blood sample in each Period.
- •9. Subjects without any evidence of impaired glucose tolerance in 2:00 hours oral glucose tolerance test.
排除标准
- •1. Volunteers having a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or any of its related group of drugs 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 or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
- •4. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •5. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
- •6. Participation in a drug research study within 90 days prior to dosing of this study.
- •7. Blood loss or whole blood donation within 90 days prior to drug administration.
- •8. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
- •9. History of addiction to any recreational drug or drug dependence.
- •10. 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.
- •11. 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.
- •12. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period.
- •13. Positive results for alcohol breathe analysis during the study check-in of each period.
- •14. History of pre-existing bleeding disorder.
- •15. Difficulty in swallowing solids like tablets or capsules.
- •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
相似试验
已完成
1 期
Study on 100 IU/mL Insulin Glargine injectioCTRI/2020/05/025383Virchow Biotech Private Limited24
已完成
不适用
A study to monitor the safety and to assess thesteady-state bioequivalence of Imatinib Mesylate 400 mg tablets of SunPharmaceutical Industries Ltd, India in Chronic Myeloid Leukemia (CML) patientsCTRI/2014/03/004484Sun Pharmaceutical Industries Ltd36
已完成
Unknown
Bioequivalence study of Liposomal Amphotericin B 50 mg/vial of Bharat Serums and Vaccines Ltd.CTRI/2023/05/052602Bharat Serums and Vaccines Ltd
尚未招募
不适用
Comparative oral bioequivalence study of DICOMEX (Clozapine) 100 mg tablet ofLaboratorios Recalcine S.A., Chile and Clozaril® (Clozapine) 100 mg tablet of NovartisPharmaceutical CorporatioCTRI/2015/10/006303aboratorios Recalcine SA36
尚未招募
1 期
An open label, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Ticagrelor tablets 90 mg of Dr. Reddy laboratories limited comparing with that of BRILINTA (film coated tablets) 90 mg in healthy, adult, human subjects under fasting conditionsHealthy subjectsBioequivalence TicagrelorTCTR20210804005Bio-innova and Synchron.Co.,Ltd30