The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Unnamed facility
Sheffield, Alabama, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Plasma Concentration of Diclofenac
The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.
Time frame: 0-6 hours after first dose of diclofenac
Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination
Time frame: Baseline to Day 3/Early Termination
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Philadelphia, Pennsylvania, United States