Al-Talla Z A, Akrawi S H, Emwas A-H M
Analytical Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia.
Int J Clin Pharmacol Ther. 2011 Jul;49(7):469-76. doi: 10.5414/cp201478.
The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers.
A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC(0-∞), AUC(0-t), C(max), K(e), tmax and t(1/2) were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data.
24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19 - 45 years); height, 175.8 (10.6) cm (range 159.0 - 192.0 cm); weight, 75.6 (11.0) kg (range 58 - 101 kg); and body mass index, 24.4 (1.8) kg/m² (range 21.3 - 28 kg/m²) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms.
The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra.
本研究旨在比较在中东当地市场销售的克林霉素仿制药（克林霉素150毫克胶囊；试验制剂）与参比制剂（达力霉素C®150毫克胶囊）在健康成年男性志愿者中的药代动力学参数，并确定其生物等效性。
进行了一项单剂量、开放标签、两周期交叉研究。健康男性志愿者被随机分配接受参比制剂和试验制剂的单次治疗。同一组随后给予另一种制剂。给药后，在24小时内采集系列血样。采用高效液相色谱法（HPLC）和紫外检测法分析血样中收获的血清中的克林霉素。根据两种制剂（试验制剂和参比制剂）的血清浓度确定药代动力学参数，包括AUC(0-∞)、AUC(0-t)、C(max)、K(e)、tmax和t(1/2)。对数据进行对数转换后，对产品进行生物等效性测试。
来自约旦的24名健康成年男性志愿者（平均[标准差]年龄，28.8（7.7）岁（范围19 - 45岁）；身高，175.8（10.6）厘米（范围159.0 - 192.0厘米）；体重，75.6（11.0）千克（范围58 - 101千克）；体重指数，24.4（1.8）千克/平方米（范围21.3 - 28千克/平方米））入选并完成了研究。达力霉素C®和克林霉素®的13C NMR谱显示与18个不同碳原子相关的18条不同谱线。
统计比较表明，克林霉素®胶囊与达力霉素C®胶囊生物等效。13C CPMAS结果证实这两种药物呈现典型的克林霉素光谱。
