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Clinical Trial Details

Trial ID: L0564
Source ID: NCT05675202
Associated Drug: Tq-B3525
Title: Material Balance Study of TQ-B3525
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Magnetic Resonance Imaging
Interventions: DRUG: TQ-B3525
Outcome Measures: Primary: Peak concentration (Cmax), Maximum plasma drug concentration, Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration|Area under drug time curve (AUC 0-t), Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration, Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration|Area under drug time curve (AUC 0-last), Area under the plasma concentration-time curve from time 0 extrapolated to infinite time, Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration | Secondary: Incidence rate of adverse events, Record the number of cases, time of adverse events, including the abnormal changes in in physical examination, vital signs, 12 lead ECG, laboratory test values and other indicators., Before the first administration until it returns to normal or the level considered acceptable by the investigator
Sponsor/Collaborators: Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01
Completion Date: 2023-12
Results First Posted:
Last Update Posted: 2023-01-12
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China
URL: https://clinicaltrials.gov/show/NCT05675202