Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
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DOI：
10.1001/jama.277.15.1205
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发表时间：
1997-04-16
影响因子：
120.7
通讯作者：
Greenspan, FS
中科院分区：
文献类型：
--
作者：
Dong, BJ;Hauck, WW;Greenspan, FS
客观。-比较Synthroid、Levoxine（Levoxine已更名为Levoxyl）和2种通用左旋甲状腺素钠制剂的相对生物利用度。单盲（主要研究者设盲）、随机、4向交叉试验。设置。-门诊病人- 22名女性甲状腺功能减退症谁是临床和化学甲状腺功能正常，并接受左旋甲状腺素钠，0.1或0.15毫克。所有患者均接受4种左旋甲状腺素产品中的每一种，为期6周，剂量与研究前方案相同，无洗脱期。药物顺序在研究开始前随机确定。所有4种产品的曲线下面积、血清浓度达峰时间、甲状腺素、三碘甲状腺原氨酸的血清浓度峰值和游离甲状腺素指数。所有数据分析均在产品代码揭盲前完成。4种产品之间在总甲状腺素、总三碘甲状腺原氨酸或游离甲状腺素指数的曲线下面积或血清峰浓度方面无显著差异。尽管与其他产品相比，Synthroid使总血清三碘甲状腺原氨酸浓度上升更快，血清三碘甲状腺原氨酸总峰浓度更高，但这些差异无统计学意义（P= 0.08）。在90%置信区间（0.8-1.25）内，证实了食品和药物管理局的相对生物等效性标准（P
Objective.-To compare relative bioavailability of Synthroid, Levoxine (Levoxine has been renamed Levoxyl), and 2 generic levothyroxine sodium preparations.Design.-Single-blind (primary investigators blinded), randomized, 4-way crossover trial.Setting.-Ambulatory care.Patients.-Twenty-two women with hypothyroidism who were clinically and chemically euthyroid and were receiving levothyroxine sodium, 0.1 or 0.15 mg.Interventions.-All patients received each of the 4 levothyroxine products for 6-week periods in the same dosage as their prestudy regimen with no washout period. The order of the drug sequences was randomly determined before study initiation.Main Outcome Measures.-Area under the curve, time to peak serum concentrations, and peak serum concentrations of thyroxine, triiodothyronine, and free thyroxine index for all 4 products.Results.-All data analyses were completed prior to unblinding of the product codes. No significant differences between the 4 products were found in area under the curve or peak serum concentrations of total thyroxine, total triiodothyronine, or free thyroxine index, Although Synthroid produced a more rapid rise in total serum triiodothyronine concentration and a higher total peak serum triiodothyronine concentration than the other products, these differences were not statistically significant (P=.08). The Food and Drug Administration criterion for relative bioequivalence within 90% confidence intervals (0.8-1.25) was demonstrated (P