<正> BACKGROUND Voglibose is an alpha- glucosidase inhibitor. Due to negligible oral absorption, measuring drug concentration in the blood is impractical. So we proposed a pharmacodynamic assessment method to reflec...
<正> BACKGROUND Voglibose is an alpha- glucosidase inhibitor. Due to negligible oral absorption, measuring drug concentration in the blood is impractical. So we proposed a pharmacodynamic assessment method to reflect drug effect, and this study aimed to validate this *** A placebo - controlled, selective two - period clinical study was conducted in 20 healthy male subjects. Period Ⅰ: On day 1. subjects received a placebo and a sucrose - rich fluid meal 20 min after dosing. Blood samples were taken during 3 hours. On day 2. subjects received 0.3 mg voglibose instead of *** Ⅱ: 9 subjects in whom effects of drug were observed in Period Ⅰ participated in a multiple dose study (placebo: 8. 11 pm on day - 1. and 9 am on day 1 / voglibose: 2. 8. 11 pm on day 1. and 9 am on day 2). RESULTS The average percent decreases of AUEClh (area under the serum glucose level- time curve to 1h) and Gmax (maximum serum glucose level) were 19.6% (P<0.001) and 22.2% (P<0.001). respectively. CONCLUSIONS Significant drug effects of voglibose were revealed after multiple doses. Changes of AUEClh and Gmax compared to placebo may be alternative parameters to AUC and Cmax for an equivalence study.
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