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To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide injection + Victoza | Experimental | Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle. |
|
| Victoza +Liraglutide injection | Experimental | Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide injection | Drug | Human glucagon-like peptides-1 analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma drug concentration(Cmax) | Maximum (peak) plasma drug concentration | 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15. |
| Time to reach maximum (peak) plasma concentration following drug administration (Tmax) | Time to maximum concentration | 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | The area under the plasma concentration curve from 0 to infinity | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. |
| Terminal disposition rate constant/terminal rate constant (λz) | Apparent end elimination rate constant | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. |
| Elimination half-life (t1/2) | The time required for the highest concentration of the drug in plasma to decrease by half | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. |
| Apparent total clearance of the drug from plasma after oral administration (CL/F) | Apparent total body clearance | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. |
| Apparent volume of distribution after non-intravenous administration (Vd/F) |
| Measure | Description | Time Frame |
|---|---|---|
| body temperature | abnormal body temperature | 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 |
| pulse | abnormal pulse |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36883362 | Derived | Xu Z, Liu Z, Wang Y, Xue J, Chang T, Cui Y, Cheng Y, Liu G, Wang W, Zhou Y, Yu S, Ren Q, Yang W, Qu X, Chen J, Chen X, Deng Q, Yang H, Wang X. Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial. Expert Rev Clin Pharmacol. 2023 Apr;16(4):363-370. doi: 10.1080/17512433.2023.2188192. Epub 2023 Mar 8. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Victoza | Drug | Human glucagon-like peptides-1 analogue |
|
Apparent volume of distribution |
| 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. |
| Bioavailability (systemic availability of the administered dose) | Relative bioavailability | 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15. |
| Adverse Event, Serious Adverse Event and Drug Combination | Monitor the safety indicators of subjects during the trial | up to day 15 |
| 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 |
| blood pressure | abnormal blood pressure | 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 |
| clinical symptoms | Any discomfort spontaneously reported by the subject | From the screening period to day 18 after the first administration |
| The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination) | Monitor the safety indicators of subjects during the trial,For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc,and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the screening period to day 18 after the first administration |
| The Number of participants with abnormal laboratory examinations | laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine | From the screening period to day 18 after the first administration |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |