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## Objectives: The combination of ephedrine (E) and caffeine (C) is used in herbal products for weight loss and athletic enhancement. We developed a population pharmacokinetics model (PPKM) describing E, C and the E metabolite norephedrine (NE). Methods: The PPKM was developed using NONMEM based on the simultaneous modeling on plasma samples gathered from two clinical trials. Single-doses of pharmaceutical (pharm) C and E, herbal E ϩ C and pharm E ϩ C were given; 24 subjects contributed to a total of 379 E, 352 NE and 421 C concentrations. Results: A one-compartment model with 1 st order absorption described the E and C data. The rate of conversion of E to NE was non-linear and modeled according to: dNE/dtϭV max E/(KmϩE)Ϫ KeNE. Parameters E pharm CV% C CV% Parameters NE CV% Ke (L/min) 1.95 Ϫ3 10 Vmax (g/min) 1.92 Ϫ4 10 CL (L/min) 0.069 16 Km (g/L) 5.1 43 Vd (L) 315 18 38.6 20 Ke (1/min) 0.036 45 Ka (1/min) 0.033 63 0.064 50 We detected a 34% increase in relative bioavailability (Fϭ1.5) after the herbal vs. the pharmaceutical E administration (Fϭ1). Simultaneous administration of C reduced E rate of absorption by 41%. Conclusions: We successfully described the PK of E, and NE, the a

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Author

V Sethuraman

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

2004

Language

EN

Field

Medicine (Health Sciences)