건강한 한국인 자원자에서 보글리보스 제제의 약효 동등성 평가 항목 선정을 위한 위약 대조, 단회 및 반복 투여 후 약력학 특성 비교 임상시험 (A Placebo-Controlled, Single and Multiple Dose Study to Investigate the Appropriate Parameters for Evaluation of Pharmacodynamic Equivalence of Voglibose in Healthy Korean Volunteers)

서지정보

· 발행기관 : 대한임상약리학회
· 수록지 정보 : Translational and Clinical Pharmacology / 21권 / 1호 / 63 ~ 70페이지
· 저자명 : 장경호, 조상헌, 김정렬, 정재용, 임경수, 장인진, 유경상

초록

Background: Voglibose is an α-glucosidase inhibitor. The purpose of this study was to evaluate the pharmacodynamic characteristics of voglibose for determining the appropriate study design and parameters for a pharmacodynamic equivalence study of voglibose.
Methods: This study consisted of two studies. The single dose study had an open and single sequence design. Nineteen subjects received placebo and then one tablet of voglibose on two consecutive days with sucrose. The multiple dose study was performed with the similar design, except that it was a multiple dose of the single dose study. Nine subjects who showed an effective response in the single dose study received placebo three times and then voglibose 4 times on two consecutive days. Serial blood samples for pharmacodynamic parameters were taken until 180 mins after each administration. The baseline adjusted maximum serum glucose level (Gmax) and area under the serum glucose level-time profiles were determined and compared.
Results: In the single dose study, the difference in Gmax was -10.6 ± 28.7 mg/dL. The area under the serum glucose concentration-time curve (AUGC0-1h) of placebo and voglibose were 7825.0 ± 1145.3 mg․min/dL, 7907.5 ± 917.2 mg․min/dL, respectively. In the multiple dose study, the difference in Gmax was 46.6 ± 16.1 mg/dL. The AUGC0-1h of placebo and voglibose were 8138.6 ± 721.9 mg․min/dL and 6499.7 ± 447.2 mg․min/dL, respectively. The Gmax and AUGC0-1h of the multiple dose study was significantly different between placebo and voglibose in paired t-test.
Conclusion: The differences in Gmax and AUGC0-1h are suitable for pharmacodynamic parameters to evaluate bioequivalence of voglibose.

영어초록

Background: Voglibose is an α-glucosidase inhibitor. The purpose of this study was to evaluate the pharmacodynamic characteristics of voglibose for determining the appropriate study design and parameters for a pharmacodynamic equivalence study of voglibose.
Methods: This study consisted of two studies. The single dose study had an open and single sequence design. Nineteen subjects received placebo and then one tablet of voglibose on two consecutive days with sucrose. The multiple dose study was performed with the similar design, except that it was a multiple dose of the single dose study. Nine subjects who showed an effective response in the single dose study received placebo three times and then voglibose 4 times on two consecutive days. Serial blood samples for pharmacodynamic parameters were taken until 180 mins after each administration. The baseline adjusted maximum serum glucose level (Gmax) and area under the serum glucose level-time profiles were determined and compared.
Results: In the single dose study, the difference in Gmax was -10.6 ± 28.7 mg/dL. The area under the serum glucose concentration-time curve (AUGC0-1h) of placebo and voglibose were 7825.0 ± 1145.3 mg․min/dL, 7907.5 ± 917.2 mg․min/dL, respectively. In the multiple dose study, the difference in Gmax was 46.6 ± 16.1 mg/dL. The AUGC0-1h of placebo and voglibose were 8138.6 ± 721.9 mg․min/dL and 6499.7 ± 447.2 mg․min/dL, respectively. The Gmax and AUGC0-1h of the multiple dose study was significantly different between placebo and voglibose in paired t-test.
Conclusion: The differences in Gmax and AUGC0-1h are suitable for pharmacodynamic parameters to evaluate bioequivalence of voglibose.

참고자료

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