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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Effect of food on the pharmacokinetics and pharmacodynamics of an oral ghrelin agonist (ARD-07) in healthy subjects.
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Effect of food on the pharmacokinetics and pharmacodynamics of an oral ghrelin agonist (ARD-07) in healthy subjects.

机译：食物对健康受试者中口服生长激素释放肽激动剂（ARD-07）的药代动力学和药效学的影响。

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ARD-07 (also known as EP01572) is a peptidomimetic growth hormone secretagogue that can be administered orally. The primary objective of this study is to determine the effects of a meal on the oral bioavailability of ARD-07 after a single oral dose (0.5 mg/kg). In addition, the pharmacodynamic effects (growth hormone release, insulin-like growth factor-1 concentrations) and the tolerability of ARD-07 are investigated in this open-label, randomized, crossover study. Sixteen healthy subjects (8 males, 8 females) receive ARD-07 on 2 different days; the treatment consists of a single oral dose of ARD-07 (0.5 mg/kg body weight), once with and the second day without a test meal. Plasma kinetics of ARD-07 and pharmacodynamic effects are quantified by specific assays. Results are given as mean +/- SEM: The area under the curve for 0 to 24 hours is approximately twice as high without food (27.8 +/- 4.1) than with food (13.7 +/- 1.2; P = .002). The maximum observed ARD-07 concentration relative to dose administration (C(max)) is more than twice as high without food (10.6 +/- 1.6 ng/mL) than with food (4.4 +/- 0.5 ng/mL; P = .001). C(max) of growth hormone occurs at a significantly (P = .001) later stage with food (C(max) = 13.0 +/- 3.5 ng/mL) than without food (37.1 +/- 5.3 ng/mL). Food has a marked effect on the absorption of ARD-07: there is a significant difference in bioavailability between administration of oral ARD-07 with and without food.
机译：ARD-07（也称为EP01572）是可以口服给药的拟肽生长激素促分泌剂。这项研究的主要目的是确定单次口服剂量（0.5 mg / kg）后进餐对ARD-07口服生物利用度的影响。此外，在这项开放标签，随机，交叉研究中，研究了药代动力学作用（生长激素释放，胰岛素样生长因子-1浓度）和ARD-07的耐受性。 16位健康受试者（8位男性，8位女性）在2天不同的时间接受ARD-07;该治疗包括一次口服ARD-07（0.5 mg / kg体重），一次含餐，第二天不含测试餐。 ARD-07的血浆动力学和药效学作用通过特定的测定方法进行定量。结果以平均值+/- SEM的形式给出：0至24小时的曲线下面积约为不食用食物（27.8 +/- 4.1）的两倍，是食用食物（13.7 +/- 1.2; P = .002）的两倍。相对于剂量给药（C（max）），观察到的最大ARD-07最高浓度是不食用食物（10.6 +/- 1.6 ng / mL）时的最高两倍（4.4 +/- 0.5 ng / mL; P = .001）。与不食用食物（37.1 +/- 5.3 ng / mL）相比，食用食物（C（max）= 13.0 +/- 3.5 ng / mL）的生长激素C（max）发生的时间要晚得多（P = .001）。食物对ARD-07的吸收具有显着影响：口服和不食用食物时，口服ARD-07的生物利用度存在显着差异。

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