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

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

July 11, 2020

Study Completion Date

July 29, 2020

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.

Trial Locations (1)

Medical Facility, Tempe