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Clinical Trial Details

Trial ID: L5859
Source ID: NCT05029076
Associated Drug: Liraglutide Injection
Title: Human Bioequivalence Test of Liraglutide Injection
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Liraglutide injection|DRUG: Victoza
Outcome Measures: Primary: 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), 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-05-21
Completion Date: 2019-07-01
Results First Posted:
Last Update Posted: 2021-08-31
Locations: Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, Jilin, 130021, China
URL: https://clinicaltrials.gov/show/NCT05029076