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A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

ClinicalTrials.gov · COMPLETED, 2013

24 participants

Abstract

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.

Conditions: Pharmacokinetics of Isavuconazole, Pharmacokinetics of Metformin, Healthy Subjects.

Primary outcome: Pharmacokinetics (PK) of metformin in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast); PK of metformin in plasma: AUC from the time of dosing to infinity (AUCinf); PK of metformin in plasma: Maximum Concentration (Cmax).

Enrollment: 24 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: 24 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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