title: Comparative bioavailability of two oral suspensions of naproxen sodium.
abstract: 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.
authors.affiliation: Departamento de Farmacología, Instituto Nacional de Pediatría, Secretaŕia de Salud, México, DF México.
authors.forename: Miriam del Carmen
authors.initials: Mdel C
authors.lastname: Carrasco-Portugal
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Herrera
authors.forename: Gerardo
authors.initials: G
authors.lastname: Reyes-García
authors.forename: Roberto
authors.initials: R
authors.lastname: Medina-Santillán
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Flores-Murrieta
mesh_terms: 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
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007202:Indicators and Reagents; D013535:Suspensions; D009288:Naproxen