Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
200
Trial Sponsor
Clinical Trial Start Date
May 4, 2023
0Primary Completion Date
June 1, 2023
0Study Completion Date
June 1, 2023
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
TBP-PI-HBr0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
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 Volunteers0
Last Updated
July 11, 2023
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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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