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CTRI Number  CTRI/2022/06/043468 [Registered on: 23/06/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare profiles of Test Liraglutide with Reference Victoza® in healthy adult human subjects 
Scientific Title of Study   A randomized open label two treatment two period two sequence crossover comparative bioavailability study of Single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injection in pre-filled pen of Biocon Pharma Limited India with Single dose (0.6 mg) of Victoza® (liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S Denmark administered subcutaneously in healthy adult human subjects under fasting condition 
Trial Acronym  LIRAPK 
Secondary IDs if Any  
Secondary ID  Identifier 
SYNCD-024-22 Version 1:0 Date: 02:05:2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhusudhan RL 
Designation  Principal Investigator 
Affiliation  Syngene International Limited 
Address  Human Pharmacology Unit Syngene International Limited Clingene House Tower 1 Semicon Park Electronic City Phase II Hosur Road Banglore India

Bangalore
KARNATAKA
560100
India 
Phone  0806633773  
Fax  0806332722  
Email  Madhu.Gowda@syngeneintl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhusudhan RL 
Designation  Principal Investigator 
Affiliation  Syngene International Limited 
Address  Human Pharmacology Unit Syngene International Limited Clingene House Tower 1 Semicon Park Electronic City Phase II Hosur Road Banglore India

Bangalore
KARNATAKA
560100
India 
Phone  0806633773  
Fax  0806332722  
Email  Madhu.Gowda@syngeneintl.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhusudhan RL 
Designation  Principal Investigator 
Affiliation  Syngene International Limited 
Address  Human Pharmacology Unit Syngene International Limited Clingene House Tower 1 Semicon Park Electronic City Phase II Hosur Road Banglore India

Bangalore
KARNATAKA
560100
India 
Phone  0806633773  
Fax  0806332722  
Email  Madhu.Gowda@syngeneintl.com  
 
Source of Monetary or Material Support  
Biocon Pharma Limited Special Economic Zone, Plot No.5, Phase IV, Bommasandra Post, Jigani Link Road, Bengaluru, Karnataka – 560 099, India. Tel: 080 2808 2808 Fax: 080 2852 3423  
 
Primary Sponsor  
Name  Biocon Pharma Limited  
Address  Special Economic Zone, Plot No.5, Phase IV, Bommasandra - Jigani Link Road, Bommasandra Post Bangalore, Karnataka- 560 099, 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 Madhusudhan RL  Syngene International Limited  Room no 02 Human Pharmacology Department Division Clinical Development Tower I Semicon Park Electronic City Phase II Hosur Road
Bangalore
KARNATAKA 		 080663322773
080663322722
Madhu.Gowda@syngeneintl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee (ACE-IEC) Top Floor B portion, of Nandanam Building, No. 1, B. Channasandra, OMBR 5th Main Road Bangalore- 560043, Karnataka, India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult Healthy Human subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liraglutide injection   Single dose (0.6mg), once daily, administered Subcutaneously, duration one day. 
Comparator Agent  Victoza®  Victoza®: Single dose (0.6mg), once daily, administered Subcutaneously, duration one day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy adult male and/or female subjects within the age range of 18 to 45 years [both inclusive]

2. Weight not less than 50 kg for male and 45 kg for female and BMI 18.50 to 30.00 kg/m2 [both inclusive].

3. Willingness and capability to provide written informed consent to participate in the study and agree to comply with the protocol requirements.

4. Subject should be literate.

5. Subjects who have no evidence of any underlying disease conditions during screening performed within 21 days prior to first dosing.

6. Subjects whose screening laboratory values, vital signs, Oxygen saturation (SpO2 %), ECG and Chest-X ray are within the normal limits; or if not, considered by physician/principal investigator to be of no clinical significance.

7. Subjects with normal levels of HbA1c (glycosylated haemoglobin).

8. Subjects should be non-alcoholic, non-smoker [defined as someone who has stopped smoking for a year before the date of screening] and should not be consuming tobacco containing products.

9. Male subjects must be using condom and another effective method of birth control if they are having sex with a woman of child-bearing potential. These measures are required during the study and for at least three months after the last Liraglutide dose. Contraceptive usage requirement will be conveyed during the inform consent process.

10. Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device (IUD) plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.). These measures are required during the study and for at least three months after the last Liraglutide dose and contraceptive usage requirement will be conveyed during the inform consent process.

11. Postmenopausal women for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy have been performed). 
 
ExclusionCriteria 
Details  1. Known history or presence of the following:
a) Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, ocular, endocrine (including diabetes), immunologic, dermatologic, venereal, neurological, musculoskeletal or psychiatric disease/disorder.
b) Asthma, urticaria or other allergic reactions after taking any medication.
c) Alcohol dependence, alcohol abuse or drug abuse (marijuana [THC], cocaine, morphine, benzodiazepines, barbiturates and amphetamine) for past one year.
d) Serious non-healing wound/ulcer/bone fracture or recurrent mouth ulcers, stomatitis, oral mucositis.
2. Hypersensitivity or contraindication to Liraglutide, related chemical substances or to any of the excipients in the formulation.
3. Presence of dermatological abnormalities at the injection site before dosing.
4. History of thyroid diseases.
5. Use of Liraglutide or Exenatide within 3 months before enrolment in to the study.
6. Recurrent severe hypoglycemia (more than one episode within the past 12 months).
7. Hypoglycemia unawareness, or severe autonomic neuropathy.
8. Subjects with type 1 & 2 diabetes mellitus or diabetic ketoacidosis.
9. Subjects with inflammatory bowel disease and diabetic gastroparesis.
10. Personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.
11. History of pancreatitis, stones in gallbladder (gallstones).
12. History of increasing shortness of breath or trouble breathing (especially when lie down), swelling or fluid retention (especially in the feet, ankles or legs), an unusually fast increase in weight, unusual tiredness.
13. Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
14. Consumption of xanthine containing products, or alcohol within 48 h prior to dosing.
15. Consumption of grapefruit or its products/juice within 7 days prior to dosing.
16. Found positive in breath alcohol test done during period I check-in and inability to abstain from alcohol till the end of the study.
17. Found positive in urine drug screening during period I check-in.
18. Found positive in HIV-1 and/or 2 and/or Hepatitis B and/or C tests during screening.
19. Any difficulty to take / while taking study formulation.
20. Refuse to abstain from food for at least 10 h prior to dosing and at least 4 h after dosing in each period.
21. Received any medication [including over-the-counter products] except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) prior to 14 days of enrolment.
22. Use of enzyme-modifying drugs or herbal products within the 30 days prior to first dosing, or within a period of 5 half-lives of that agent, whichever is longer.
23. Donation of 500 mL or more blood within the 90 days prior to the first dose of study drug.
24. Subjects who have participated in another clinical study in the past 90 days prior to commencement of this study.
25. Pregnant females as determined by positive test for pregnancy at screening or during period I check-in.
26. Lactating females.
27. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to subject’s safety, as per the investigator’s judgment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome parameters- Cmax, AUC0-t and AUC0-inf will be measured based on Pharmacokinetic end points till day-02
To characterize the pharmacokinetic profile of single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injection in pre-filled pen of Biocon Pharma Limited, India and single dose (0.6 mg) of Victoza® (liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S Denmark administered subcutaneously 		 Time up to 5 half lives post dose on profiling day 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax, AUC%_Extrap, Kel, t1/2, clearance (CL/F), volume of distribution (Vz/F)
Safety and tolerability comparison of Test Liraglutide with Victoza® 		 Secondary Outcome will be measured based on Pharmacokinetic end points till day 2

Vital signs are assessed at within 2 h before dosing of investigational products and at 2.00, 4.00, 10.00, 24.00 and 48.00 hours post-dose.

Random Blood Sugar test using Glucometer will be performed at 2.00 and 12.00 h post dose 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/06/2022 
Date of Study Completion (India) 12/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The proposed comparative bioavailability study will be having following study design:

Test formulation [T] of single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injection in pre-filled pen of Biocon Pharma Limited, India with Reference formulation single dose (0.6 mg) of Victoza® (liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S, Denmark.

A single dose of either of the test [T] or reference [R] product will be administered subcutaneously to each subject in each period under fasting condition.


 
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