盐酸吡格列酮胶囊生物等效性研究

 目的研究盐酸吡格列酮胶囊在健康人体内的药动学和相对生物利用度，进行生物等效性评价。方法20名男性健康志愿者双周期随机交叉单剂量po盐酸吡格列酮片剂和胶囊30 mg，服药间隔为1周，采用高效液相色谱法测定血浆中吡格列酮浓度。结果两种制剂主要药动学参数无显著性差异，片剂和胶囊的c_max分别为(1172.43±347.01)和(1 108.8±375.55)μg·L^-1；t_max分别为(2.16±0.89)和(1.79±1.10) h；t_1/2分别为(7.75±1.79)和(8.20±2.10) h；AUC_0～tn分别为(12 268.01±3 542.93)和(11623.17±4 038.65) μg·h·L^-1。盐酸吡格列酮胶囊的相对生物利用度为(94.48±15.78)%。结论方差分析和双向单侧t检验结果表明两种制剂具有生物等效性。

Studies on bioequivalence and relative bioavailability of pioglitazone hydrochloride capsule in healthy volunteers

OBJECTIVE To evaluate the bioequivalence and relative bioavailability of pioglitazone hydrochloride capsule in healthy volunteers. METHOD 20 healthy male volunteers were randomized into A and B groups.A single dose (30 mg) of pioglitazone hydrochloride capsules and tablets were given respectively according to an open 2 way crossover study design.The washout period was 1 week.The plasma concentrations of pioglitazone were determined by HPLC method. RESULTS The pharmacokinetic parameters of pioglitazone hydrochloride tablets and capsules were as follows:c_max(1172.43±347.01) and (1108.8±375.55)μg·L^-1;t_max(2.16±0.89) and (1.79±1.10) h;t_1/2(7.75±1.79) and (8.20±2.10) h；AUC_0～tn(12 268.01±3542.93) and (11623.17±4038.65) μg·h·L^-1，respectively.The relative bioavailability of pioglitazone hydrochloride capsule was (94.48±15.78)%. CONCLUSION The results of variance analysis and two one side t test showed that the two formulations were of bioequivalence.