生物利用度
生物等效性
最大值
药代动力学
交叉研究
克林霉素
剂型
药理学
吸收(声学)
医学
志愿者
色谱法
化学
抗生素
安慰剂
生物
生物化学
物理
病理
声学
替代医学
农学
作者
Grace Goode,Santosh Wagh,David Irby,Dejian Ma,Richard F. Jacobs,Gregory L. Kearns,Hassan Almoazen
标识
DOI:10.1080/10837450.2019.1624771
摘要
Background: Clindamycin’s bitter taste and odor is known to affect treatment adherence in children. Recently, a formulation of clindamycin HCl complexed with ion exchange resin IRP 69 was shown to mask the bitter taste. Because of the potential benefit of this formulation for children, a pilot study using a porcine model was conducted to evaluate its relative bioavailability.Methods: A randomized two-way crossover study design using six (n = 6) healthy male piglets 10–12 kg was used to evaluate the absorption profiles and pharmacokinetic parameters of clindamycin from the resinate complex formulation (Test) compared to a commercialized reference suspension. A dose of 15 mg/kg was administered orally by gastric gavage to each piglet followed by repeated blood sampling over 12 h. A wash-out period of 48 h occurred between treatments. Plasma concentration vs. time data was analyzed by non-compartmental analysis.Results: The mean relative bioavailability of clindamycin from the resinate formulation was 78.8%. A two-tailed, paired Student t test yielded a p < 0.05 for AUC∞ and Tmax parameters. A two one-sided test (TOST) suggested a difference in AUC∞ and Cmax for the Test formulation compared to the reference formulation according to the FDA’s criteria for bioequivalence.Conclusion: The bioavailability of clindamycin from this novel oral formulation supports continued evaluation of the drug in humans for potential pediatric applications.
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