TY - JOUR
T1 - A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers
AU - Prasaja, Budi
AU - Harahap, Yahdiana
AU - Lusthom, Windy
AU - Setiawan, Evy C.
AU - Ginting, Mena B.
AU - Hardiyanti,
AU - Lipin,
PY - 2011/6
Y1 - 2011/6
N2 - The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam®) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single- dose, open-label, randomized two-way crossover design following an overnight fasting. A one-week washout period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography- tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax and t1/2 were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC0-t, AUC0-∞, Cmax and t1/2 were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.
AB - The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam®) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single- dose, open-label, randomized two-way crossover design following an overnight fasting. A one-week washout period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography- tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax and t1/2 were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC0-t, AUC0-∞, Cmax and t1/2 were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.
KW - Bioavailability
KW - Bioequivalence
KW - Pharmacokinetic
KW - Sustained-release
KW - Tamsulosin
UR - http://www.scopus.com/inward/record.url?scp=80052538142&partnerID=8YFLogxK
U2 - 10.1007/s13318-011-0033-1
DO - 10.1007/s13318-011-0033-1
M3 - Article
C2 - 21432621
AN - SCOPUS:80052538142
SN - 0378-7966
VL - 36
SP - 109
EP - 113
JO - European Journal of Drug Metabolism and Pharmacokinetics
JF - European Journal of Drug Metabolism and Pharmacokinetics
IS - 2
ER -