None listed
Conditions
Interventions
Intervention1: Semaglutide Injection 2.4 mg/0.75 mL: single dose of 2.4 mg/0.75 mL
Route of administration: Subcuteneous
Control Intervention1: WEGOVY
(semaglutide) injection 2.4 mg/0.75 mL: Single dose of 2.4 mg/0.75 mL will be administered subcutaneoulsy
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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/m 6. Participant who had HbA1c levels lessthan 5.7%. 7. Normal 12-lead ECG. 8. Non-smokers and non-alcoholics. 9. Normal chest X-ray 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).
Exclusion criteria
Exclusion criteria: 1. Volunteers with a known 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. History or presence of cholelithiasis 6. Participant with a personal history of medullary Thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2). 7. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting). 8. Any history of intolerance to (lactose, fructose, galactose). 9. Participants with secondary causes of obesity for example hypothalamic, monogenic or endocrine Causes Mental health. 10. History of major depressive disorder within 2 years before screening. 11. Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder. 12. A lifetime history of suicidal attempt. 13. History of confirmed diagnosis of bulimia nervosa disorder. 14. History or presence of pancreatitis acute or chronic. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary PK parameters: Cmax and AUC0-tTimepoint: 804 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary PK Parameters: AUC0-inf, Tmax, AUC% extrapolation, Kel, T1/2 Vd and clearence.Timepoint: 840 hours | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed