Effect of relative bioavailability of domperidone maleate combined with antacids in healthy volunteers

Objective To study the effect of antacids(famotidine and Cascara,bismuth subnitrate and magnesium carbonate)on the pharmacokinetics of domperidone maleate in healthy volunteers.Methods A single oral dose of domperidone maleate 10 mg was given to 10 healthy volunteers under the condition of untaking or taking antacids.Plasma domperidone concentration was determined by a validated LC/MS/MS method.Pharmacokinetic parameters were calculated by WinNonLin 5.0 software and compared the parameters by Spss 12.0 software.Results Under untaking and taking antacids conditions,the main pharmacokinetic parameters were as follows:tmax were(0.85±0.24)and(2.20±1.78)h,Cmax were(9.68±5.37)and(7.18±4.12)μg·L-1,AUC0~tnwere(38.18±19.76)and(49.96±10.35)μg·h·L-1.The absorption of domperidone maleate was delayed significantly,the peak concentration were reduced and area under curve were increased insignificantly when antacids was taken.Conclusion Antacids had significant effects on the absorption rate and had insignificant effects on the absorption extent of domperidone maleate after a single oral dose in healthy volunteer.