To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.
40 mg (1 x 40 mg capsule) omeprazole administered QD
Medical Facility
Phoenix, Arizona, United States
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Area under the curve extrapolated to infinity (AUC0-∞).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Percent of AUC0-inf extrapolated (AUC%extrap)
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Maximum plasma concentration (Cmax).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Time to the maximum plasma concentration (Tmax).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Terminal elimination half-life (t½).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent total body clearance (CL/F)
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Time frame: Day 2 (Periods 1 and 2) and Day 6 (Period 3)
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.
Time frame: 12 to 14 days after the last dose of study drug
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