The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
2 x Naproxen Sodium 220 mg under fasting conditions
2 x Diphenhydramine HCl 25 mg under fasting conditions
Unnamed facility
Hackensack, New Jersey, United States
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of naproxen sodium
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)
Time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 6 weeks
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2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions