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First received: May 03, 2023

Clinical Trial: A Study to Compare Two Bioanalytical Assays for Tebipenem

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Volunteers

Study Type: INTERVENTIONAL


Official Title: An Open-Label, Single-Center, Single-Period Study to Compare Two Bioanalytical Assays for Tebipenem Following Administration of Oral Tebipenem Pivoxil Hydrobromide in Healthy Adult Volunteers

Brief Summary: The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.

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