Tolerability.
gastrointestinal tract
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
Overall, 12 (60%) subjects reported 24 treatment-emergent adverse events (TEAEs), where the most common were those of the gastrointestinal tract (Incidence of adverse events by treatment (safety population)Adverse events are classified according to MedDRA Version 23.0. TEAE = Treatment-emergent adverse event. Although a subject may have had 2 or more adverse events, the subject was counted only once within a category. The same subject may appear in different categories.Treatment A: 600 mg (2 × 300 mg tablets) TBP-PI-HBr administered at Hour 0 on Day 1.Treatment B: 20 mL Mylanta Maximum Strength Classic Flavor (800 mg aluminum hydroxide/80 mg simethicone per 10 mL) oral suspension with 600 mg (2 × 300 mg tablets) TBP-PI-HBr at Hour 0 on Day 1.Treatment C: 40 mg (1 × 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 × 300 mg tablets) TBP-PI-HBr administered at Hour 0 on Day 5.Treatment C1: Omeprazole alone (prior to coadministration of TBP-PI-HBr).Treatment C2: TBPM-PI-HBr + Omeprazole (after coadministration of TBP-PI-HBr).