The pharmacokinetic interaction potential of the new proton-pump inhibitor lansoprazole and theophylline was assessed in a double-blind, two-period (13-day duration per period), multiple-dose crossover study in 14 healthy male volunteers. Lansoprazole 60 mg or placebo once daily was coadministered with anhydrous theophylline 200 mg four times daily. Plasma theophylline concentrations were quantitated via high-performance liquid chromatography. Lansoprazole did not appear to affect substantially the absorption profile or clearance of theophylline. Theophylline area under the plasma concentration-versus-time curve over the 6-h dosing interval decreased slightly (13%) but statistically significantly during lansoprazole coadministration. As the magnitude of this effect was small, this interaction is likely to be clinically insignificant.