A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Empagliflozin in Subjects with Type 2 Diabetes Mellitus
Abstract
This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.
Conditions: Patients.
Primary outcome: GMR for Cmax of empagliflozin; GMR for AUC0-24h of empagliflozin; GMR for Cmax of dorzagliatin; GMR for AUC0-24h of dorzagliatin; Adverse events; Abnormal vital signs; Abnormal clinical laboratory findings; 12-lead ECG.
Enrollment: 16 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
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