The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (\<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to \<17 years of age with post-procedure orthodontic pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.
JBR Clinical Research LLP
Salt Lake City, Utah, United States
Apparent Clearance (CL/F) of Acetaminophen/Naproxen Sodium
CL/F is defined as apparent clearance of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Apparent Central Volume of Distribution (Vc/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Vc/F is defined as apparent central volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Apparent Peripheral Volume of Distribution (Vp/F) After Oral Dosing of Acetaminophen/Naproxen Sodium
Vp/F is defined as apparent peripheral volume of distribution after oral dosing of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Apparent Inter-compartmental Clearance (Q/F) of Acetaminophen/Naproxen Sodium
Q/F is defined as apparent inter-compartmental clearance of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
First-order Absorption Rate Constant (Ka) of Acetaminophen/Naproxen Sodium
Ka is defined as first-order absorption rate constant of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Maximum Plasma Concentration (Cmax) of Acetaminophen/Naproxen Sodium
Cmax is defined as maximum plasma concentration of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Time of occurrence of Maximum Plasma Concentration (Tmax) of Acetaminophen/Naproxen Sodium
Tmax is defined as time of occurrence of maximum plasma concentration of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Area Under the Plasma Concentration versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable Plasma Concentration (AUC[0-t])
AUC(0-t) is defined as area under the plasma concentration versus time curve from start of drug administration until the time of the last measurable plasma concentration of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Area Under the Plasma Concentration versus Time Curve From Start of Drug Administration Until Infinity (AUC[0-infinite])
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from start of drug administration until infinity of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Terminal Elimination Rate Constant (lambda[z]) of Acetaminophen/Naproxen Sodium
Lambda(z) is defined as terminal elimination rate constant of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Half Life (t1/2) of Acetaminophen/Naproxen Sodium
T1/2 is defined as half life of acetaminophen/naproxen sodium.
Time frame: Pre-dose up to 48 hours post dose
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence that occurs in participants after they have signed an informed consent for the study. The event does not need to have a suspected causal relationship with the investigational product (IP).
Time frame: Up to 3 days
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