| CTRI Number |
CTRI/2025/11/097878 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
BIOEQUIVALENCE STUDY OF SEMAGLUTIDE INJECTION 8 mg/3 mL (Dose:2 mg) - FASTING |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, single-dose, parallel, bioequivalence study
of Semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ®
(semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo
Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants
under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AR089-25; Version 1; Dated 09 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkateshwarlu Yeldandi MD |
| Designation |
Principal Investigator |
| Affiliation |
ADVITY Research Pvt. Ltd., |
| Address |
3
rd
& 4
th
Floors, Archies Continental,
P. No. 2A, 3, S. No. 1094 & 1095,
Adj: Kukatpally Metro station,
Kukatpally
Hyderabad
TELANGANA
500072
India |
| Phone |
914069089999 |
| Fax |
|
| Email |
venkateshwarlu.y@advityresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Medical Officer |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Plot No 319, 320, 3rd floor,
East Avenue, Swamy Ayappa Society,Madhapur, Hyderabad, India – 500081.
Hyderabad
TELANGANA
500081.
India |
| Phone |
9866911717 |
| Fax |
|
| Email |
hnandigala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Medical Officer |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Plot No 319, 320, 3rd floor,
East Avenue, Swamy Ayappa Society,Madhapur, Hyderabad, India – 500081.
TELANGANA
500081.
India |
| Phone |
9866911717 |
| Fax |
|
| Email |
hnandigala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advity Research Private Limited Metro Station Kukatpally, Bagh Ameer, Sumitra Nagar Colony,
Kukatpally, Hyderabad, Telangana 500072, India Phone: 040 6908 9999 |
|
|
Primary Sponsor
|
| Name |
Virchow Biotech Private Limited |
| Address |
Virchow Biotech Private Limited, Plot No. 4, S.V.Co-op, Industrial Estate,
Jeedimetla (India) - 500055, Telangana, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkateshwarlu Yeldand |
Advity Research Pvt. Ltd., |
3rd & 4th Floors, Archies
Continental, Adj:
Kukatpally Metro stationKukatpally, Hyderabad
TELANGANA
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
914069089999
venkateshwarlu.y@advityresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vasavi Medical and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subbjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ozempic
®
(semaglutide) injection 8 mg/3 mL |
Subjects will receive a single dose of 2 mg of dose subcutaneously |
| Intervention |
Semaglutide Injection 8mg/3 mL |
Subjects will receive a single dose of 2 mg of dose subcutaneously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy adult human participants between 18-45 years of age (including both).
2. Participants able to communicate effectively.
3. Voluntary participation.
4. Participants willing to give written informed consent and adhere to all the requirements of
this protocol.
5. Body mass index in the range of 18.5 to 29.9 kg/m²
6. Participant who had HbA1c levels lessthan5.7%.
7. Normal 12-lead ECG.
8. Non-smokers and non-alcoholics.
9. Normal chest X-ray (valid for 180 days).
10. Normal values of laboratory parameters.
11. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL.
12. Participant willing to abstain from all kinds of having caffeine/xanthine containing foods or
beverages from 72.00 hours prior to admission until the last blood sample collection in the
study. Participants willing to abstain from all kinds of grapefruit/citrus/St john’s wort
containing food and juices from at least 07 days prior to admission until the last blood sample
collection in study.
13. Participants willing to follow approved birth control methods (a double barrier method) for
the duration of the study and for 07 days after last dose as judged by the investigator(s),
such as Condom with spermicide, Condom with diaphragm, or abstinence. Participants
should also not donate sperm during the study conduct.
14. Female participants:
of child bearing potential willing to practice an acceptable method of birth
control for the duration of the study and for at least 07 days after last doses
such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or
abstinence.
Or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the participant).
|
|
| ExclusionCriteria |
| Details |
1. Volunteers with known a history of contraindication or hypersensitivity (e.g., anaphylaxis) to
semaglutide related class of drugs and any of its ingredients.
2. Use of any prescribed medication or OTC medicinal products including vitamins and herbal
drugs within the 2 weeks prior to commencement of the study or at least 5 half-lives of the
compound whichever period is longer prior to study admission.
3. 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, ophthalmic disorder/disease,
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 of diabetic ketoacidosis.
5. Participant with a personal or family history of Medullary Thyroid Carcinoma (MTC) or MEN2
(Multiple Endocrine Neoplasia type 2).
6. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities,
dizziness, weakness and sometimes fainting).
7. Any history of intolerance to (lactose, fructose, galactose).
8. Participants with secondary causes of obesity for example hypothalamic, monogenic or
endocrine Causes Mental health.
9. History of major depressive disorder within 2 years before screening.
10. Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder.
11. A lifetime history of suicidal attempt.
12. History of confirmed diagnosis of bulimia nervosa disorder.
13. History or presence of pancreatitis acute or chronic.
14. History or presence of cholelithiasis
15. History of Type 1 diabetes.
16. Significant illness less than 28 days prior dosing.
17. Participants with a current history of abrupt discontinuation of alcohol, benzodiazepines,
barbiturates, or antiepileptic drugs.
18. History or presence of gastrointestinal (GI) inflammation.
19. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic
epidermal necrolysis (TEN).
20. Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
21. Participation in drug study within 90 days prior to dosing.
22. Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug
administration.
23. A depot injection or implant of any drug within 3 months prior to the first dose of study
medication.
24. Intolerance to venipuncture.
25. History of addiction to any recreational drug or drug dependence.
26. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of
study period, e.g., fasting due to religious reasons.
27. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines,
cannabinoids and barbiturates) in urine during the admission of study period.
28. Positive results for alcohol consumption during the admission of study period.
29. History of pre-existing bleeding disorder.
30. Difficulty with donating blood.
31. Blood pressure on the day of admission of study period
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
32. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission
of study period.
33. 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.
34. Females with positive results on serum pregnancy test.
35. Females currently breast-feeding.
36. Female participant who has used implanted or injected hormonal contraceptives anytime
during the 6 months prior to study or used oral hormonal contraceptives within 14 days
before dosing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary PK parameters:
Cmax and AUC0-t |
804 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary PK Parameters:
AUC0-inf, Tmax, AUC% extrapolation, Kel, T1/2, Vd and clearence.
|
840 hrs |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open label, balanced, randomized, two-treatment, single dose, parallel,bioequivalence study of semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ® (semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants under fasting conditions.
The Primary Objective of the study is to demonstrate the bioequivalence between of semaglutide Injection 8 mg/3 mL (Test) of Virchow Biotech, Hyderabad, India with Ozempic ® (semaglutide) injection 8 mg/3 mL (2.68mg/mL) (Dose: 2 mg) pre-filled pen (Reference) of Novo Nordisk A/S DK-2880 Bagsvaerd Denmark in normal, healthy, adult, human participants under fasting conditions
The Secondary Objective is To monitor the safety and tolerability of single dose of semaglutide in thestudy participants. |