CompletedInterventionalPhase 1Last updated Sep 4, 2020

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

An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Overview

ClinicalTrials.gov ID: NCT04368585
Lead Sponsor: Spero TherapeuticsINDUSTRY
Brief 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.
Study Type: Interventional

Status

Overall Status: Completed
Start Date: Jul 1, 2020Actual
Primary Completion Date: Aug 8, 2020Actual
Completion Date: Aug 21, 2020Actual

Study Record Dates

First Submitted: Apr 9, 2020
First Submitted that Met QC Criteria: Apr 27, 2020
First Posted: Apr 30, 2020Actual
Last Update Submitted that Met QC Criteria: Sep 2, 2020
Last Update Posted: Sep 4, 2020Actual
Last Verified: Sep 2020

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