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

NCT04421885 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-08-12

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference

600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.

DRUG

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Melnick · Spero Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-07-11
Completion
2020-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421885 on ClinicalTrials.gov