None listed
Conditions
Interventions
Intervention1: Liraglutide injection: Dose: 0.6 mg
Control Intervention1: Victoza®: Dose:0.6mg
Sponsors
Levim Biotech LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects between 18-45 years 2. Who has given written informed consent and willing to participate in the study 3. No evidence of underlying disease during the pre-study screening 4. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. 5. Who are non-smoker, non-tobacco (in any form) users and without a history of alcohol or drug abuse. 6. Who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR. 7. 12 lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study 8. Who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. 9. Female volunteers who are having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in. 10. Male subjects and/or Female subjectâ??s partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study.
Exclusion criteria
Exclusion criteria: 1. Female volunteers who are nursing motherslactating women or are found positive in beta hCG test (for female volunteers only). 2. History/presence of Alcohol or drug abuse. 3. History/presence of smoking or tobacco (in any form) users. 4. Asthma, urticaria or other allergic type reactions after taking any medication. 5. Clinically significant illness within 4 weeks before the start of the study. 6. Hypersensitivity to heparin. 7. History of clinically relevant allergy (except for untreated, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 8. History of vascular collapse. 9. Who is scheduled for surgery any time during study or within 07 days after study completion. 10. History of difficulty in donating blood. 11. Who is participating in any other clinical or pharmacokinetic / bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 12. Who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin e.g. St. Johnâ??s Wort) within 14 days prior to administration of IP in Period 1, including topical medication meant for systemic absorption. 13. Who has unsuitable veins for repeated vein puncture. 14. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 15. Who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 16. Who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Single dose and multiple dose Pharmacokinetic profiles of Liraglutide injection of Levim Biotech with Victoza®Timepoint: Time up to 5 half lives post dose on profiling day | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability comparison of biosimilar Liraglutide with VictozaTimepoint: Vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) are assessed at predefined interval as per protocol | — |
Countries
India
Contacts
Public ContactDr Kadalmani Krishnan
Ecron Acunova Limited
Outcome results
None listed