A Bioequivalence Study of HR20031 Tablet in Healthy Subjects
Abstract
The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.
Conditions: Type 2 Diabetes.
Primary outcome: Pharmacokinetics parameters of SHR3824 in the fed state: Cmax; Pharmacokinetics parameters of SP2086 in the fed state: Cmax; Pharmacokinetics parameters of Metformin in the fed state: Cmax; Pharmacokinetics parameters of SHR3824 in the fed state: AUC0-t; Pharmacokinetics parameters of SP2086 in the fed state: AUC0-t; Pharmacokinetics parameters of Metformin in the fed state: AUC0-t; Pharmacokinetics parameters of SHR3824 in the fed state: AUC0-inf (if applicable); Pharmacokinetics parameters of SP2086 in the fed state: AUC0-inf (if applicable); Pharmacokinetics parameters of Metformin in the fed state: AUC0-inf (if applicable).
Enrollment: 96 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: 96 participants or records.
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