TY - JOUR
T1 - Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects
AU - Harahap, Yahdiana
AU - Prasaja, Budi
AU - Azmi, Fahmi
AU - Lusthom, Windy
AU - Sinandang, Theresia
AU - Felicia, Vita
AU - Yusvita, Lia Yumi
AU - Panjaitan, Lianna Y.
PY - 2016/3
Y1 - 2016/3
N2 - Aim: To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. Methods: 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon- Spray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞;, and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. Results: The estimated point and 90% confidence intervals (CI) for AUC0-t, AUC0-∞, and Cmax for rosuvastatin were 95.21% (87.56 . 103.53%), 95.76% (88.01 . 104.18%), and 99.33% (89.37 . 110.41%), respectively. Conclusion: These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.
AB - Aim: To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. Methods: 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon- Spray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞;, and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. Results: The estimated point and 90% confidence intervals (CI) for AUC0-t, AUC0-∞, and Cmax for rosuvastatin were 95.21% (87.56 . 103.53%), 95.76% (88.01 . 104.18%), and 99.33% (89.37 . 110.41%), respectively. Conclusion: These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.
KW - Bioequivalence
KW - HMG-CoA reductase inhibitor
KW - LCMS/MS
KW - Pharmacokinetic
KW - Rosuvastatin
UR - http://www.scopus.com/inward/record.url?scp=84961254471&partnerID=8YFLogxK
U2 - 10.5414/CP202345
DO - 10.5414/CP202345
M3 - Article
C2 - 26073355
AN - SCOPUS:84961254471
SN - 0946-1965
VL - 54
SP - 212
EP - 216
JO - International Journal of Clinical Pharmacology and Therapeutics
JF - International Journal of Clinical Pharmacology and Therapeutics
IS - 3
ER -