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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBP-PI-HBr 600 mg | Experimental | Healthy participants meeting eligibility criteria will receive a single oral dose of TBP-PI-HBr 600 mg tablets (2 x 300 mg) on Day 1 under fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBP-PI-HBr | Drug | TBP-PI-HBr tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Tebipenem (TBP) Samples With Converted (From Whole Blood Measurements) and Measured Plasma Concentrations That Have a Difference not Exceeding ±20% of the Mean of the Concentrations | Pre dose and at multiple time points post dose on Day 1 | |
| Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-∞) of TBP | Pre dose and at multiple time points post dose on Day 1 | |
| Maximum Plasma Concentration (Cmax) of TBP | Pre dose and at multiple time points post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose of study drug up to Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria as per protocol may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioPharma Services | Creve Coeur | Missouri | 63141 | United States |
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| ID | Term |
|---|---|
| C500135 | tebipenem |
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