NCT04421885

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

An Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover, Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-07-11
• Completion: 2020-07-29
• First posted: 2020-06-09
• Last updated: 2020-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study