drugset / Trial / NCT06727136
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.
Timeline
- Start
- 2024-11-20
- Primary completion
- 2025-04-22
- Completion
- 2025-04-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TBP-PI-HBr | Unknown | 600 mg | Oral |
| Subject | TBP-PI-HBr | Unknown | 900 mg | Oral |
| Subject | TBP-PI-HBr | Unknown | 1200 mg | Oral |
Indications
No indication recorded.