首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >The influence of food on the bioavailability of a twice-daily controlled release carbamazepine formulation.
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The influence of food on the bioavailability of a twice-daily controlled release carbamazepine formulation.

机译:食物对每日两次控释卡马西平制剂的生物利用度的影响。

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摘要

Carbatrol, a new dosage form of carbamazepine (CBZ), was developed consisting of three different types of pellets (immediate release, controlled release, and enteric release). The objective of this study was to explore the influence of food on absorption of CBZ. This was a randomized, open-label, single-dose crossover study conducted in 12 healthy volunteers. Treatments were 2 x 200 mg Carbatrol with a high-fat meal, fasted, or sprinkled over applesauce (but otherwise fasted). Each subject received one dose of each treatment separated by a washout period of at least 2 weeks. CBZ bioequivalence was established based on the equivalence of AUC (extent of absorption) in all three conditions. Carbatrol may be taken with or without food or the capsule opened and sprinkled on food.
机译:卡巴特罗是一种新的卡马西平(CBZ)剂型,它由三种不同类型的小丸组成(立即释放,控释和肠溶释放)。这项研究的目的是探讨食物对CBZ吸收的影响。这是在12位健康志愿者中进行的随机,开放标签,单剂量交叉研究。处理方法是将2 x 200 mg卡巴特尔与高脂餐食一起食用,禁食或撒在苹果酱上(但禁食)。每个受试者接受一种剂量的每种治疗,间隔至少2周。 CBZ生物等效性是根据在所有三种条件下的AUC等效性(吸收程度)确定的。可以在有或没有食物的情况下服用甲萘酚,或将胶囊打开并撒在食物上。

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