A Randomized, Open-Label, Two-Period, Crossover Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects
Abstract
This is a randomized, open-label, two-period, crossover Phase 1 to assess the impact of CIN-107 on the pharmacokinetics (PK) of metformin and the safety and tolerability of coadministration of CIN-107 and metformin as compared to metformin alone.
Conditions: Hypertension.
Primary outcome: Maximum plasma concentration (Cmax); Time to Cmax (Tmax); Area under the concentration-time curve (AUC) from time 0 to 72 hours; Maximum plasma concentration (Cmax) of metformin; Time to Cmax (Tmax) of metformin; AUC from time 0 to the time of last quantifiable plasma concentration of metformin; AUC from time 0 to infinity of metformin; Percent of AUC extrapolated of metformin; Terminal phase elimination half-life of metformin; Cumulative amount of metformin excreted in the urine (Ae) of metformin; Renal clearance (calculated as Ae/AUC) of metformin; Fraction of the dose excreted renally of metformin.
Enrollment: 27 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized 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: 27 participants or records.
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