Bioequivalence study on isoniazid rifampicin and pyraginamide capsule in healthy volunteers
Yan Liu
Abstract
Yan Liu
Abstract
Objective To study relative bioavailability of isoniazid,rifampicin and pyraginamide capsule in twenty healthy volunteers.Methods Isoniazid,rifampicin and pyraginamide in plasma were determined by HPLC method,respectively.Results The pharmacokinetics parameters of the tested and referred drugs were: Rifampicin:tmax(1.7±0.5)and(1.6±0.3)h,Cmax(7.95±1.30)mg/L and(7.87±1.21)mg/L,AUC0-t(49.82±8.38)mg/(L·h) and(48.35±8.12)mg/(L·h),the relative bioavailability of Rifampicin was(103.2±7.0)%.Isoniazid:tmax(1.70±0.25)h and (1.72±0.26)h,Cmax(5.76±0.85)mg/L and(5.89±0.94)mg/L,AUC0-t(22.78±9.34)mg/h/L and(21.86±7.92)mg/(L·h),the relative bioavailability of isoniazid was(103.6±12.3)%.Pyraginamide:tmax(2.45±0.43) and(2.45±0.32)h,Cmax(21.18±0.98)mg/L and(21.56±1.02)mg/L,AUC0-t(304.0±27.93)mg/L and(298.2±29.06)mg/L,the relative bioavailability of Pyraginamide was(102.1±5.3)%.Conclusion The tested drag was bioequivalent with the referred.
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Objective To study relative bioavailability of isoniazid,rifampicin and pyraginamide capsule in twenty healthy volunteers.Methods Isoniazid,rifampicin and pyraginamide in plasma were determined by HPLC method,respectively.Results The pharmacokinetics parameters of the tested and referred drugs were: Rifampicin:tmax(1.7±0.5)and(1.6±0.3)h,Cmax(7.95±1.30)mg/L and(7.87±1.21)mg/L,AUC0-t(49.82±8.38)mg/(L·h) and(48.35±8.12)mg/(L·h),the relative bioavailability of Rifampicin was(103.2±7.0)%.Isoniazid:tmax(1.70±0.25)h and (1.72±0.26)h,Cmax(5.76±0.85)mg/L and(5.89±0.94)mg/L,AUC0-t(22.78±9.34)mg/h/L and(21.86±7.92)mg/(L·h),the relative bioavailability of isoniazid was(103.6±12.3)%.Pyraginamide:tmax(2.45±0.43) and(2.45±0.32)h,Cmax(21.18±0.98)mg/L and(21.56±1.02)mg/L,AUC0-t(304.0±27.93)mg/L and(298.2±29.06)mg/L,the relative bioavailability of Pyraginamide was(102.1±5.3)%.Conclusion The tested drag was bioequivalent with the referred.
Key concepts: Bioavailability, Bioequivalence, Cmax, Isoniazid, Rifampicin, Pharmacokinetics, Pharmacology, Medicine