drugset / Trial / NCT04368585
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Non-randomizedCrossoverOpen-labelOther
Summary
To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2020-08-08
- Completion
- 2020-08-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aluminum hydroxide | Unknown | 1600 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | — |
| Subject | Simethicone | Other / unclassified | 1600 mg | Oral |
| Subject | TBPM-PI-HBr | Small molecule | 600 mg | Oral |
| Subject | magnesium hydroxide | Unknown | 1600 mg | Oral |
Indications
No indication recorded.