Bioequivalence Study of Locally Manufactured Cetirizine Tablets in Ghana

The datasets were reverse-phase High-Performance Liquid Chromatographic concentrations of unchanged reference and test cetirizine excreted in the urine of twelve healthy male volunteers after taking 10 mg of cetirizine tablet. The data collection aimed to study the bioequivalence of locally manufactured cetirizine tablets with the innovator counterpart. We designed the study under the (WHO, 2006) guideline for bioequivalence study in a two-way-crossover design, fed and fasted mode. Samplings include blank urine samples before the drug intake, followed by subsequent samples throughout the 24-hour study duration. The values are mean concentrations of triplicate readings together with the standard deviations. Further interpretations of the datasets can provide more insight into the pharmacokinetics study of locally manufactured cetirizine tablets. It can also serve as a model to design computational simulations for pharmacokinetics studies.

本研究数据集包含了十二名健康男性志愿者服用10毫克西替利嗪片剂后，尿液中西替利嗪未变化参照物和测试物的反相色谱浓度。数据收集的目的是研究本地生产的西替利嗪片剂与原研产品的生物等效性。本研究依据世界卫生组织(WHO, 2006)关于生物等效性研究的双交叉设计、进食及禁食模式指南进行设计。采样包括药物摄入前的空白尿液样本，以及随后在24小时研究期间内的连续样本。数据值包括三次测量的平均浓度及标准差。对数据集的进一步解读可为本地生产西替利嗪片剂的药代动力学研究提供更多见解，并可作为一种设计药代动力学研究计算模拟的模型。