로살탄 제제인 살로탄®정의 코자®정에 대한 생물학적동등성 연구 = Bioequivalence Study of Two Losartan Formulations, Sarlotan® Tablet and Cozaar® Tablet

다국어 초록 (Multilingual Abstract)

Background: Losartan is a nonpeptide angiotensin II receptor antagonist used in hypertension. The
objective of this study was to evaluate the bioequivalence of two losartan formulations, Sarlortan® 50
mg tablet (Chong Kun Dang, Pharmaceutical Corp. Seoul, Korea) as a test drug and Cozaar® 50 mg
tablet (MSD Korea, Co., Ltd., Seoul, Korea) as a reference drug. The bioavailability was evaluated
based on the requirement of 20% deviation at a power of 80%.
Methods: This study had a randomized, open-label, 2-period, crossover design. There was a 12-hour
treatment period for each formulation, with a 1-week washout period between formulations. Each
subject received one 50 mg tablet of the reference or test formulation of losartan. Blood samples were
obtained during the 12-hour period after the dose in each treatment period. Concentrations of losartan in
plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection
(LC/MS/MS). The primary pharmacokinetic parameters were Cmax (maximum concentration) and AUCt
(area under the concentration-time curve from time 0 to the last sampling time).
Results: A total number of 36 healthy malevolunteers participated in the study and 33 volunteers
completed both treatment periods (age range, 19-29 years; mean height, 176.3 cm mean weight, 67.8
kg). The 90% CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug)
were 0.96 ~ 1.07 for AUCt and 0.83 ~ 1.21 for Cmax, lying within the range of the 80% to 125%
bioequivalence criterion.
Conclusion: The obtained results indicated that pharmacokinetic exposure to Sarlortan® tablet was
bioequivalent to that of Cozaar® tablet.

다국어 초록 (Multilingual Abstract)

Background: Losartan is a nonpeptide angiotensin II receptor antagonist used in hypertension. The
objective of this study was to evaluate the bioequivalence of two losartan formulations, Sarlortan® 50
mg tablet (Chong Kun Dang, Pharmaceutical Corp. Seoul, Korea) as a test drug and Cozaar® 50 mg
tablet (MSD Korea, Co., Ltd., Seoul, Korea) as a reference drug. The bioavailability was evaluated
based on the requirement of 20% deviation at a power of 80%.
Methods: This study had a randomized, open-label, 2-period, crossover design. There was a 12-hour
treatment period for each formulation, with a 1-week washout period between formulations. Each
subject received one 50 mg tablet of the reference or test formulation of losartan. Blood samples were
obtained during the 12-hour period after the dose in each treatment period. Concentrations of losartan in
plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection
(LC/MS/MS). The primary pharmacokinetic parameters were Cmax (maximum concentration) and AUCt
(area under the concentration-time curve from time 0 to the last sampling time).
Results: A total number of 36 healthy malevolunteers participated in the study and 33 volunteers
completed both treatment periods (age range, 19-29 years; mean height, 176.3 cm mean weight, 67.8
kg). The 90% CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug)
were 0.96 ~ 1.07 for AUCt and 0.83 ~ 1.21 for Cmax, lying within the range of the 80% to 125%
bioequivalence criterion.
Conclusion: The obtained results indicated that pharmacokinetic exposure to Sarlortan® tablet was
bioequivalent to that of Cozaar® tablet.

참고문헌 (Reference)

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