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Clinical Trial Details

Trial ID: L3710
Source ID: NCT05146869
Associated Drug: Dbpr108 Tablets
Title: A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DBPR108 tablets
Outcome Measures: Primary: Peak plasma concentration (Cmax) of DBPR108 tablets, Cmax of DBPR108 tablets will be assessed after single-dose and multiple-dose administration, Day 1-Day 11|Area under the plasma concentration versus time curve (AUC) of DBPR108 tablets in plasma, AUC of DBPR108 tablets will be assessed after single-dose and multiple-dose administration, Day 1-Day 11|Half-life(t1/2) of DBPR108 tablets, T1/2 of DBPR108 tablets will be assessed after single-dose and multiple-dose administration, Day 1-Day 11|Apparent volume of Distribution(Vz/F)of DBPR108 tablets, Vz/F of DBPR108 tablets will be assessed after single-dose and multiple-dose administration, Day 1-Day 11|CL/F of DBPR108 tablets, Apparent clearance(CL/F) of DBPR108 tablets will be assessed single-dose and multiple-dose administration, Day 1-Day 11|Change from baseline in dipeptidyl peptidase-IV inhibition rate, Change from baseline in dipeptidyl peptidase-IV inhibition rate will be assessed after single-dose and multiple-dose administration, Day 1-Day 11|Change from baseline in active glucagon-like peptide1 concentration, Change from baseline in active glucagon-like peptide1 concentration will be assessed after single-dose and multiple-dose administration, Day 1-Day 11 | Secondary: The number of patients with adverse events, The number of patients with adverse events as a measure of safety and tolerability., Throughout the study period, with an average of 1 months|Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point, ECG monitoring includes P-R, QT and QTc intervals in ms., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).|Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point., Vital signs monitoring includes respiratory rate and pulse in times per minute, Throughout the study period, with an average of 1 months|Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point., Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg., Throughout the study period, with an average of 1 months|Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point., Vital signs monitoring includes body temperature in degrees Celsius, Throughout the study period, with an average of 1 months|Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point., Physical examination includes mucocutaneous, lymphonodus, head and neck,chest, abdomen, spinal column, musculoskeletal, nervous system, Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).|Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point., Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10\^9 /L., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)|Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point., Blood biochemistry test includes total protein, albumin and albumin in g/L., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)|Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point., Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, amylase, alkaline phosphatase and in U/L., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)|Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point., Blood biochemistry test includes ureophil, glucose, triglyceridein, total cholesterol, high-density lipoprotein, low-density lipoprotein, sodium, potassium, chlorine, calcium in mmol/L, Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)|Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point., Blood biochemistry test includes total bilirubin and serum creatinine in umol/L., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day 11)|Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point., Routine urine test includes the count of leukocyte, and red blood cell in high-power field., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)|Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point., Routine urine test includes glucose, protein, ketonein in negative or positive., Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Sponsor/Collaborators: Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-30
Completion Date: 2022-03-28
Results First Posted:
Last Update Posted: 2022-04-05
Locations: Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing, 100000, China
URL: https://clinicaltrials.gov/show/NCT05146869