Comparative bioavailability of two oral suspensions of naproxen sodium.
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: C(max) 43.93 +/- 1.83 and 44.91 +/- 2.15 microg/ml, t(max) 2.38 +/- 0.21 and 1.83 < or = 0.19 h, AUC(72 h) 721.73 +/- 18.47 and 722.55 +/- 19.07 microg x h/ml for reference and test formulations, respectively. Maximal concentration, AUC(72 h) and AUC(infinity). 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.
Carrasco-Portugal
Miriam del Carmen
Mdel C
Departamento de Farmacología, Instituto Nacional de Pediatría, Secretaŕia de Salud, México, DF México.
Herrera
Jorge E
JE
Reyes-García
Gerardo
G
Medina-Santillán
Roberto
R
Flores-Murrieta
Francisco Javier
FJ
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D008800:Mexico; D009288:Naproxen / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007202:Indicators and Reagents; D013535:Suspensions; D009288:Naproxen