Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
1 tablet 660 mg administered orally once daily
1 tablet 660 mg administered orally once daily
1 tablet 660 mg administered orally once daily
Cmax (maximum plasma concentration) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-24 (partial area under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium
Time frame: Days 0, 1, 2, and 3
λz (terminal elimination rate constant)
Time frame: Days 0, 1, 2, and 3
t1/2 (terminal half life)
Time frame: Days 0, 1, 2, and 3
Adverse events (AEs) collection
Time frame: up to 50 days
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1 tablet 220 mg administered orally three times daily
Serious adverse events (SAEs) collection
Time frame: up to 50 days
Vital signs: sitting blood pressure
Time frame: up to 50 days
Vital signs: repiratory rate
Time frame: up to 50 days
Vital signs : pulse rate
Time frame: up to 50 days
Clinical Laboratory data
Blood and urine samples were collected according to standard medical guidelines at the Screening Visit. In addition, hematology and chemistry were obtained at the end of the study (EOS).
Time frame: up to 50 days
Physical examination findings
Brief physical examination, including height, weight and BMI, was performed at the Screening Visit and at EOS
Time frame: up to 50 days