건강한 남성 자원자에서 실데나필 제제인 플리즈구강용해필름과 비아그라®의 약동학적 특성 및 안전성의 비교평가 (Comparison of the Population Pharmacokinetics and Safety Between Please Orally Soluble Film and VIAGRA® in Healthy Male Volunteers)

서지정보

· 발행기관 : 대한임상약리학회
· 수록지 정보 : Translational and Clinical Pharmacology / 21권 / 1호 / 26 ~ 33페이지
· 저자명 : 홍태곤, 이종태, 전상일, 백정기, 김현일, 곽성신, 박수준, 한승훈, 임동석

초록

Background: The objective of this study was to compare the pharmacokinetics and safety between newly developed sildenafil (Please Orally Soluble Film) and sildenafil citrate (VIAGRAⓇ) after single oral administration in healthy Korean male subjects.
Methods: A randomized, open-label, single dose, 2-way crossover study was conducted in 50 healthy male subjects. Each sequence group consisted of 25 subjects, received a single oral 50 mg dose of Please Orally Soluble Film (test formulation) or VIAGRAⓇ (reference formulation) by study period. Blood samples were obtained during a 24-hour period after dosing. Sildenafil and its metabolite concentrations were determined using validated LC-MS/MS. A non-compartmental pharmacokinetic analysis was performed. Safety was assessed through monitoring of adverse events, vital sign check-up, physical examination, laboratory tests and electrocardiography.
Results: All enrolled participants completed the study. The point estimates and 90 % confidence intervals of log transformed Cmax and AUClast of the test formulation in comparison to those of reference formulation were 0.9294(0.8353 - 1.0341) and 0.9415 (0.8869 – 0.9994) respectively. The analysis of variance showed no significant influences of formulation, sequence and period on the pharmacokinetic parameters. The frequencies of adverse events were not statistically different between the formulations. No serious adverse event was observed or reported.Conclusion: Please Orally Soluble Film could be considered bioequivalent to VIAGRAⓇ and had similar safety properties in healthy Korean male subjects.

영어초록

Background: The objective of this study was to compare the pharmacokinetics and safety between newly developed sildenafil (Please Orally Soluble Film) and sildenafil citrate (VIAGRAⓇ) after single oral administration in healthy Korean male subjects.
Methods: A randomized, open-label, single dose, 2-way crossover study was conducted in 50 healthy male subjects. Each sequence group consisted of 25 subjects, received a single oral 50 mg dose of Please Orally Soluble Film (test formulation) or VIAGRAⓇ (reference formulation) by study period. Blood samples were obtained during a 24-hour period after dosing. Sildenafil and its metabolite concentrations were determined using validated LC-MS/MS. A non-compartmental pharmacokinetic analysis was performed. Safety was assessed through monitoring of adverse events, vital sign check-up, physical examination, laboratory tests and electrocardiography.
Results: All enrolled participants completed the study. The point estimates and 90 % confidence intervals of log transformed Cmax and AUClast of the test formulation in comparison to those of reference formulation were 0.9294(0.8353 - 1.0341) and 0.9415 (0.8869 – 0.9994) respectively. The analysis of variance showed no significant influences of formulation, sequence and period on the pharmacokinetic parameters. The frequencies of adverse events were not statistically different between the formulations. No serious adverse event was observed or reported.Conclusion: Please Orally Soluble Film could be considered bioequivalent to VIAGRAⓇ and had similar safety properties in healthy Korean male subjects.

참고자료

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