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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04368585

Public ClinicalTrials.gov record NCT04368585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 3:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT04368585
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Spero Therapeutics
Industry
Enrollment
20 participants

Conditions and interventions

Interventions

  • Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) Drug
  • 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) Drug
  • Omeprazole Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2020
Primary completion
Aug 7, 2020
Completion
Aug 20, 2020
Last update posted
Sep 3, 2020

2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Medical Facility Phoenix Arizona 85283

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04368585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2020 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04368585 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →