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NCT04421885 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

A Phase 1 study, sponsored by Spero Therapeutics.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT04421885 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 36 participants.

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The verdict

NCT04421885, a Phase 1 study, has completed, sponsored by Spero Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.

Interventions

  • DRUG Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
  • DRUG Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2020-06-01
Est. Completion 2020-07-29
Phase Phase 1

Sponsor

Spero Therapeutics

14 total trials

What the Registry Record Tells You About NCT04421885

The ClinicalTrials.gov registry entry for NCT04421885 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference is the first listed.

NCT04421885 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04421885 about?

NCT04421885 is a clinical study titled "Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects". A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.

What is the current status of trial NCT04421885?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-06-01. Estimated completion is 2020-07-29.

What interventions are being tested in trial NCT04421885?

The interventions under investigation include: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference (DRUG), Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test (DRUG).

Who is sponsoring clinical trial NCT04421885?

This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.