A randomized, single dose, open label, two treatment, two-period, cross-over, bioequivalence study between the test product, Semaglutide injection 2mg/1.5mL (0.5 mg dose) of Cipla Ltd., India with the reference product, Wegovy (semaglutide 2mg/1.5mL) 0.5 mg FlexTouch solution for injection in pre-filled pen (Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark) each administered subcutaneously in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of the test
研究概览
简要总结
The study is randomized, single dose, open label, two treatment, two-period, cross-over, bioequivalence study between the test product, Semaglutide injection 2mg/1.5mL (0.5 mg dose) of Cipla Ltd., India with the reference product, Wegovy (semaglutide 2mg/1.5mL) 0.5 mg FlexTouch solution for injection in pre-filled pen (Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark) each administered subcutaneously in healthy adult human subjects under fasting conditions. Primary objective is to compare the rate and extent of absorption of the test product, Semaglutide injection 2mg/1.5mL (0.5 mg dose) of Cipla Ltd., India, and the reference product, Wegovy (semaglutide 2mg/1.5mL) 0.5 mg FlexTouch solution for injection in pre-filled pen (Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark), each administered as 0.5mg subcutaneously in healthy adult human subjects under fasting conditions. Secondary objective is to assess the safety and tolerability of a single subcutaneous 0.5mg dose of semaglutide injection in healthy adult human subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers who give consent by signing the informed consent form after understanding the study related information about the nature, risk, and scope of the clinical study as well as the expected adverse effects of the drug.
- •Volunteers who are healthy adult between 18 to 45 years of age (both inclusive) of Asian Indian origin.
- •Volunteers who have a Body Mass Index between 18.5 and 30 kg/m2, weighing not less than 45 kg.
- •Volunteers who have no evidence of any significant diseases or clinically significant abnormal findings during the pre-study screening, medical and medication histories, vital signs examination, physical examination, 12-lead electrocardiogram (ECG) and chest X-ray (postero-anterior view recorded in last 180 days).
- •Volunteers, whose urine alcohol test and urine test for drugs of abuse are negative and whose Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV) and antibodies to human immunodeficiency Virus (HIV) I and II are negative or non-reactive.
- •Volunteers whose pre-study screening laboratory tests are within normal limit or clinically not significant (refer Appendix I).
- •Volunteers who agree to abstain from consuming grapefruit or its products for at least 72 hours prior to dosing and until the last blood sample collection of each study period.
- •Volunteers who agree to abstain from consuming citrus fruits or their products and xanthine containing products (chocolate, tea, coffee or cola drink), for at least 24 hours prior to dosing and until the last blood sample collection of each study period.
- •Volunteers who do not have history of drug addiction or a habit of heavy drinking which is defined as regular intake of more than 2 units of alcohol per day for males and 1 unit for females (1 unit=150 mL of wine or 360 mL of beer or 45 mL of 40% alcohol) and those who agree to abstain from consuming alcohol/alcoholic products for at least 48 hours prior to dosing and until the last blood sample collection of each study period.
- •Volunteers who are non-smokers or those who are ex-smokers and have less than a 10 pack-year history of smoking and have not consumed tobacco or tobacco containing products for at least 12 months prior to screening and who agree to abstain from the same until the last blood sample collection of the last treatment period.
- •Volunteers must agree to be available for the entire study and have the ability to understand and communicate effectively with the investigators and study personnel.
- •For female volunteers: non pregnant as per pregnancy test, Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study and Child-bearing potential and not sexually active.
排除标准
- •Volunteers who have a history of known hypersensitivity to semaglutide, ondansetron or to any excipients used in the formulation or related class of drug.
- •Volunteers having difficulty in swallowing tablet.
- •Volunteers with a history of known food allergy.
- •Volunteers who have vital signs abnormalities (systolic blood pressure less than 100 or greater than 140 mm of Hg or diastolic blood pressure less than 60 or greater than 90 mm of Hg or pulse rate less than 50 beats per minute or more than 100 beats per minute) during pre-study screening and vital signs examination before check-in.
- •Volunteers who have clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, bleeding disorder, tumor/ cancer, eye, ear, nose and throat disease.
- •Volunteers who have suffered any clinically significant illness in the 2 weeks prior to dosing or who have been hospitalized within 3 months preceding the start of the study.
- •Volunteers who have taken any drugs that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing.
- •Volunteers who have taken any prescription medications (except ondansetron) or over-the-counter products available (including vitamins and products from natural origin such as ayurvedic, unani, siddha and homeopathic medicines) and topical medication meant for systemic absorption, within the 7 days prior to dosing.
- •Volunteers who have depot injection or an implant of any drug within 3 months prior to dosing.
- •Volunteers who have a history of difficulty in donating blood.
- •Volunteers who have donated blood (1 unit or 350 mL) within 90 days prior to dosing.
- •Volunteers who have unsuitable veins for repeated venipuncture, evidence of skin lesions on forearm or signs of venipuncture on the forearm suggestive of recent blood donation or participation in a study.
- •Volunteers who have fasting blood sugar less than 70 mg/dL and more than 125 mg/dL.
- •Volunteers who have clinically significant amylase and lipase test results.
- •Volunteers having Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/ min/1.73 m2 or more than 240 mL/ min/1.73 m2 calculated by MDRD (Modification of Diet in Renal Disease Study) formula.
- •Volunteers who have history of pancreatitis or acute gallbladder disease such as cholelithiasis or cholecystitis.
- •Volunteers who have history of diabetic retinopathy.
- •Volunteers who have a history of depression, suicidal thoughts or suicidal attempts.
- •Volunteers having personal or family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •Female volunteers who have clinically significant signs and symptoms or history of gynecological disease.
结局指标
主要结局
To compare the rate and extent of absorption of the test
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
product, Semaglutide injection 2mg/1.5mL (0.5 mg dose) of Cipla Ltd., India,
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
and the reference product, Wegovy (semaglutide 2mg/1.5mL) 0.5 mg
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
FlexTouch solution for injection in pre-filled pen (Novo Nordisk A/S, Novo
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
Allé, DK-2880 Bagsvaerd, Denmark), each administered as 0.5mg
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
subcutaneously in healthy adult human subjects under fasting conditions.
时间窗: Predose and post dose at 2.00, 8.00, 14.00, 16.00, 18.00, 20.00, 22.00, 24.00, 26.00, 28.00, 30.00, 32.00, 34.00, 38.00, 42.00, 48.00, 54.00, 60.00, 66.00, 72.00, 96.00, 144.00, 192.00, 240.00, 312.00, 408.00, 504.00, 600.00 and 696.00.
次要结局
- To assess the safety & tolerability of a single subcutaneous 0.5mg(dose of semaglutide injection in healthy adult human subjects under fasting)
研究者
Dr Pranay Tembhurne
Sitec Labs Limited