This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions. The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib
Ciprofloxacin
Celecoxib
Novum
Las Vegas, Nevada, United States
Cmax D1
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1.
Time frame: 1 day
Cmax D7
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Time frame: 7 days
AUC0-12 D1
Area under the plasma concentration versus time curve from time zero to the end of the morning 12-hour dosing interval on Day 1, as calculated by the linear trapezoidal method.
Time frame: 1 day
AUC0-12 D7
Area under the plasma concentration time curve over the morning 12-hour dosing interval on Day 7, as calculated by the linear trapezoidal method.
Time frame: 7 days
Cpre Dx
Measured pre-dose plasma concentration on Days 1, 5, 6 and 7; where D = Day 1, 5, 6 or 7; and x = m (morning dose) or e (evening dose).
Time frame: 7 days
Tmax D1
Time of the maximum measured plasma concentration on Day 1 over the morning 12-hour dosing interval on Day 1.
Time frame: 1 day
AR Treatment R
For Treatment R (reference products), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1).
Time frame: 7 days
AR Treatment T
For Treatment T (PrimeC), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1).
Time frame: 7 days
Cav D7
Average measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Time frame: 7 days
Cmin D7
Minimum measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Time frame: 7 days
Ctrough D7
Measured plasma concentration at the end of the morning dosing interval on Day 7.
Time frame: 7 days
Tmax D7
Time of the maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Time frame: 7 days
λz
First order rate constant associated with the terminal (log-linear) portion of the curve following the last dose administered on the morning of Day 7.
Time frame: 7 days
t½
The terminal half-life following the last dose administered on the morning of Day 7
Time frame: 7 days
Percent Fluctuation
Percent fluctuation over the morning 12-hour dosing interval on Day 7
Time frame: 7 days
Percent Swing
Percent swing over the morning 12-hour dosing interval on Day 7
Time frame: 7 days
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