TY - JOUR
T1 - Comparative bioavailability of two oral suspensions of naproxen sodium
AU - Carrasco-Portugal, Miriam Del Carmen
AU - Herrera, Jorge E.
AU - Reyes-García, Gerardo
AU - Medina-Santillán, Roberto
AU - Flores-Murrieta, Francisco Javier
PY - 2006
Y1 - 2006
N2 - The bioavailability of naproxen sodium (CAS 26159-34-2) after administration of two oral suspensions, reference or test (Pactens®), was compared in 24 healthy subjects. The volunteers received an oral dose of 250 mg (10 ml) in two separate sessions under fasting conditions according to a randomized cross-over design and blood samples were obtained at selected times for a period of 72 h. Plasma samples were analyzed by a high-performance liquid chromatographic method for determination of naproxen. Individual plasma concentration against time curves were constructed and pharmacokinetic parameters were obtained by non-compartmental techniques. The parameters obtained (mean ± S.E.M.) were: Cmax 43.93 ± 1.83 and 44.91 ± 2.15 μg/ml, tmax 2.38 ± 0.21 and 1.83 ± 0.19 h, AUC72 h 721.73 ± 18.47 and 722.55 ± 19.07 μg · h/ml for reference and test formulations, respectively. Maximal concentration, AUC72 h and AUC∞, were log transformed and compared by analysis of variance and ratios; in addition, 90% confidence limits were obtained. As confidence limits were included in the 80-125% range and the probability of exceeding these intervals was always lower than 0.05, it is concluded that the formulations tested are bioequivalent.
AB - The bioavailability of naproxen sodium (CAS 26159-34-2) after administration of two oral suspensions, reference or test (Pactens®), was compared in 24 healthy subjects. The volunteers received an oral dose of 250 mg (10 ml) in two separate sessions under fasting conditions according to a randomized cross-over design and blood samples were obtained at selected times for a period of 72 h. Plasma samples were analyzed by a high-performance liquid chromatographic method for determination of naproxen. Individual plasma concentration against time curves were constructed and pharmacokinetic parameters were obtained by non-compartmental techniques. The parameters obtained (mean ± S.E.M.) were: Cmax 43.93 ± 1.83 and 44.91 ± 2.15 μg/ml, tmax 2.38 ± 0.21 and 1.83 ± 0.19 h, AUC72 h 721.73 ± 18.47 and 722.55 ± 19.07 μg · h/ml for reference and test formulations, respectively. Maximal concentration, AUC72 h and AUC∞, were log transformed and compared by analysis of variance and ratios; in addition, 90% confidence limits were obtained. As confidence limits were included in the 80-125% range and the probability of exceeding these intervals was always lower than 0.05, it is concluded that the formulations tested are bioequivalent.
KW - Anti-inflammatories
KW - CAS 26159-34-2
KW - Naproxen sodium, bioavailability, bioequivalence, Mexican volunteers, suspensions
KW - Pactens®
UR - http://www.scopus.com/inward/record.url?scp=33748512093&partnerID=8YFLogxK
U2 - 10.1055/s-0031-1296756
DO - 10.1055/s-0031-1296756
M3 - Artículo
SN - 0004-4172
VL - 56
SP - 589
EP - 592
JO - Arzneimittel-Forschung/Drug Research
JF - Arzneimittel-Forschung/Drug Research
IS - 8
ER -