The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.
This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.
Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8
PPD Development, LP
Austin, Texas, United States
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t
Time frame: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf
Time frame: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: Cmax
Time frame: Days 1 and 8
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