CTRI/2025/07/090224 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On:
02/09/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study between Semaglutide injection 2mg/1.5mL with Wegovy in adult human subjects under fasting conditions.
Scientific Title of Study
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.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
0103-01-25 Version 03 Date 14 February 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pranay Tembhurne
Designation
Principal Investigator
Affiliation
Sitec Labs Limited
Address
Sitec Labs Limited
Plot Number Gen 40 TTC MIDC Behind Millennium Business Park Near Nelco Mahape Navi Mumbai India
Thane MAHARASHTRA 400710 India
Phone
9930510305
Fax
Email
pranay.tembhurne1@siteclabs.com
Details of Contact Person Scientific Query
Name
Dr Sandeep Chaubey
Designation
Manager
Affiliation
Cipla Limited
Address
Cipla Limited
R & D center North Block
LBS Road Vikhroli West
Mumbai India
Mumbai MAHARASHTRA 400083 India
Phone
8451000216
Fax
Email
sandeep.chaubey@cipla.com
Details of Contact Person Public Query
Name
Dr Sandeep Chaubey
Designation
Manager
Affiliation
Cipla Limited
Address
Cipla Limited
R & D center North Block
LBS Road Vikhroli West
Mumbai India
Mumbai MAHARASHTRA 400083 India
Phone
8451000216
Fax
Email
sandeep.chaubey@cipla.com
Source of Monetary or Material Support
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400013, Maharashtra, India
Primary Sponsor
Name
Cipla Ltd India
Address
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400013, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Pranay Tembhurne
Sitec Labs Limited
Plot No.: Gen 40, TTC MIDC, Behind Millennium Business Park, Near Nelco, Mahape, Navi Mumbai, 400 710, India Thane MAHARASHTRA
9930510305
pranay.tembhurne1@siteclabs.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Suraksha Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy adult between 18 to 45 years (both inclusive), having body mass index (BMI) between 18.5 and 30 kg/m2, weighing not less than 45 kg
Intervention / Comparator Agent
Type
Name
Details
Intervention
Semaglutide injection 2mg/1.5mL (0.5 mg dose)
Dose:Single subcutaneous 0.5 mg dose of Semaglutide injection 2mg/1.5mL. To be administered subcutaneously (in abdomen) under yellow monochromatic light in fasting conditions.
Duration: Single dose in each period
Comparator Agent
Wegovy (semaglutide 2mg/1.5mL) 0.5 mg FlexTouch solution for injection in pre-filled pen
Dose: Single subcutaneous dose of Wegovy (semaglutide 2mg/1.5mL) 0.5 mg FlexTouch solution for injection in pre-filled pen
Mode of administration To be To be administered subcutaneously (in abdomen) under yellow monochromatic light in fasting conditions.
Duration: Single dose in each period
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. 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.
2. Volunteers who are healthy adult between 18 to 45 years of age (both inclusive) of Asian Indian origin.
3. Volunteers who have a Body Mass Index between 18.5 and 30 kg/m2, weighing not less than 45 kg.
4. 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).
5. 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.
6. Volunteers whose pre-study screening laboratory tests are within normal limit or clinically not significant (refer Appendix I).
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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
ExclusionCriteria
Details
1. Volunteers who have a history of known hypersensitivity to semaglutide, ondansetron or to any excipients used in the formulation or related class of drug.
2. Volunteers having difficulty in swallowing tablet.
3. Volunteers with a history of known food allergy.
4. 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.
5. 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.
6. 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.
7. Volunteers who have taken any drugs that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing.
8. 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.
9. Volunteers who have depot injection or an implant of any drug within 3 months prior to dosing.
10. Volunteers who have a history of difficulty in donating blood.
11. Volunteers who have donated blood (1 unit or 350 mL) within 90 days prior to dosing.
12. Volunteers who have taken any investigational product or participated in any drug research study requiring blood donation within 90 days prior to dosing.
13. 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.
14. Volunteers who have fasting blood sugar less than 70 mg/dL and more than 125 mg/dL.
15. Volunteers who have clinically significant amylase and lipase test results.
16. 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.
17. Volunteers who have history of pancreatitis or acute gallbladder disease such as cholelithiasis or cholecystitis.
18. Volunteers who have history of diabetic retinopathy.
19. Volunteers who have a history of depression, suicidal thoughts or suicidal attempts.
20. Volunteers having personal or family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
21. Female volunteers who have clinically significant signs and symptoms or history of gynecological disease.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
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.
Secondary Outcome
Outcome
TimePoints
To assess the safety & tolerability of a single subcutaneous 0.5mg
dose of semaglutide injection in healthy adult human subjects under fasting
conditions.