To compare Liraglutide availability in body (Pharmacokinetics) after injection of single dose of test and reference formulatio
- Registration Number
- CTRI/2023/07/055234
- Lead Sponsor
- Biocon Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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).
1.Known history or presence of the following:
a)Cardiovascular, pulmonary, metabolic, 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/chemical 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 or presence of cancer or any other major disorder that might have an impact on the trial, as judged by investigator.
5.History of thyroid diseases.
6.Use of Liraglutide or Exenatide within 3 months before enrolment in to the study.
7.Recurrent severe hypoglycemia (more than one episode within the past 12 months).
8.Hypoglycemia unawareness, or severe autonomic neuropathy.
9.Subjects with type 1 & 2 diabetes mellitus or diabetic ketoacidosis.
10.Subjects with inflammatory bowel disease and diabetic gastroparesis.
11.Personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.
12.History of pancreatitis, stones in gallbladder (gallstones).
13.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.
14.Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
15.Consumption of xanthine containing products, or alcohol within 48 h prior to dosing.
16.Consumption of grapefruit or its products/juice within 7 days prior to dosing.
17.Found positive in breath alcohol test done during period I check-in and inability to abstain from alcohol till the end of the study.
18.Found positive in urine drug screening during period I check-in.
19.Found positive in HIV-1 and/or 2 and/or Hepatitis B and/or C tests during screening.
20.Any difficulty to take / while taking study formulation.
21.Refuse to abstain from food for at least 10 h prior to dosing and at least 4 h after dosing in each period.
22.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.
23.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.
24.Donation of 500 mL or more blood within the 90 days prior to the first dose of study drug.
25.Subjects who have participated in another clinical study in the past 90 days prior to commencement of this study.
26.Pregnant females as determined by positive test for pregnancy at screening or during period I check-in.
27.Lactating females.
28.Any other condition t
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome parameters- Cmax & AUC0-t will be measured based on Pharmacokinetic end points till day-03 <br/ ><br> <br/ ><br>To demonstrate the bioequivalence 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 Saxenda® (Liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S, Denmark, administered subcutaneously under fasting conditionTimepoint: Time upto 5 half lives post dose on profiling day
- Secondary Outcome Measures
Name Time Method Secondary parameters to compare: <br/ ><br>AUC0-inf, Tmax, AUC%_Extrap, Kel, t1/2, clearance (CL/F), volume of distribution (Vz/F), AUC0-t / AUC0-8 X 100, TLIN & LQCT <br/ ><br> <br/ ><br>Safety and tolerability comparison of Test Liraglutide with Saxenda®Timepoint: Secondary Outcome will be measured based on pharmacokinetic end points till Day-03. <br/ ><br> <br/ ><br>Vital signs are assessed at within 2 h before dosing of investigational products & at 2.00, 4.00, 10.00, 24.00 and 48.00 hours post-dose. <br/ ><br> <br/ ><br>Random Blood Sugar test using Glucometer will be performed at 2.00 and 12.00 h post dose