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Clinical Trial Details

Trial ID: L5572
Source ID: NCT03790787
Associated Drug: Empagliflozin
Title: Drug Interaction Study Between Dorzagliatin and Empagliflozin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Patients
Interventions: DRUG: Empagliflozin|DRUG: Dorzagliatin
Outcome Measures: Primary: GMR for Cmax of empagliflozin, Geometric mean ratio (GMR) between combination and empagliflozin monotherapy for Cmax of empagliflozin, up to 10 days|GMR for AUC0-24h of empagliflozin, GMR between combination and empagliflozin in monotherapy for AUC0-24h of empagliflozin, up to 10 days|GMR for Cmax of dorzagliatin, GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin, up to 15 days|GMR for AUC0-24h of dorzagliatin, GMR between combination and dorzagliatin in monotherapy for AUC0-24h of dorzagliatin, up to 15 days|Adverse events, Number of participants with AEs, up to 15 days|Abnormal vital signs, Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), up to 15 days|Abnormal clinical laboratory findings, Number of participants with abnormal clinical laboratory findings, up to 15 days|12-lead ECG, Number of participants with abnormal ECG VR,, PR, QRS and QT, up to 15 days | Secondary: iCmax of glucose, The incremental peak plasma concentration of glucose post OGTT, up to 15 days|iAUC0-4h of glucose, The incremental area under the concentration-time curve of glucose in 4 hours post OGTT, up to 15 days|iCmax of insulin, The incremental peak plasma concentration of insulin post OGTT, up to 15 days|iAUC0-4h of insulin, The incremental area under the concentration-time curve of insulin in 4 hours post OGTT, up to 15 days|iCmax of C-peptide, The incremental peak plasma concentration of C-peptide post OGTT, up to 15 days|iAUC0-4h of C-peptide, The incremental area under the concentration-time curve of C-peptide in 4 hours post OGTT, up to 15 days
Sponsor/Collaborators: Sponsor: Hua Medicine Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-18
Completion Date: 2020-03-15
Results First Posted:
Last Update Posted: 2025-03-24
Locations: Frontage Clinical Services Inc., Hackensack, New Jersey, 07601, United States
URL: https://clinicaltrials.gov/show/NCT03790787