Alvero Rita Grace Y, Aquino Rea Carmela C, Balmadrid Aline S, Balaccua Geraldo P
Pharmalytics Corporation, General Trias City, Cavite.
Pascual Laboratories, Inc., Quezon Ave., Quezon City.
Acta Med Philipp. 2024 Apr 15;58(6):30-36. doi: 10.47895/amp.vi0.7078. eCollection 2024.
Bioequivalence studies provide evidence that generic drugs can produce the same blood levels as the innovator, suggesting similar efficacy and safety and indicating interchangeability without the need to titrate dosing. This study aimed to compare the rate and extent of absorption of two simvastatin 20 mg tablets of Pascual Laboratories, Inc. with two Zocor 20 mg tablets of Merck Sharp & Dohme (I.A.) Corp. in healthy Filipinos. The study also monitored the safety and tolerability of the medications, under the same conditions. Proof of bioequivalence is required by FDA Philippines to establish the interchangeability of generic products and their innovators.
Twenty-four healthy participants were administered with a single oral dose of two 20 mg simvastatin tablets under fasting conditions, in a randomized, open-label, blind-endpoint analysis, two-way crossover study, with a washout period of one week. Pharmacokinetic blood sampling was done up to 24 h post-dose. Simvastatin was measured using Liquid Chromatography-Tandem Mass Spectrometry with a validated method. The geometric mean ratios for maximum plasma concentration (C) and area under the plasma-concentration-time curve from time zero to the last observed concentration at time 24 h (AUC) were used for bioequivalence.
All 24 participants, 12 males and 12 females, completed the study. Mean age was 24.21 years, mean weight was 58.81 kg, and mean BMI was 23.16 kg/m. The ratios of C and AUC were 102.17% (90% CI: 89.19-117.03), and 101.29% (90% CI: 86.87-118.10), respectively, and were both within the bioequivalence limits of 80% to 125%. No adverse event was reported and both formulations were well-tolerated.
Simvastatin 20 mg tablet of Pascual Laboratories, Inc. and the innovator Zocor 20 mg tablet are bioequivalent. Single two-tablet doses of both products are safe and well tolerated.
生物等效性研究提供证据表明仿制药可产生与创新药相同的血药浓度，这意味着疗效和安全性相似，并表明无需调整剂量即可互换使用。本研究旨在比较菲律宾帕斯夸尔实验室公司生产的两种20毫克辛伐他汀片与默克雪兰诺公司（I.A.）生产的两种20毫克舒降之片在健康菲律宾人中的吸收速率和程度。该研究还在相同条件下监测了药物的安全性和耐受性。菲律宾食品药品监督管理局要求提供生物等效性证明，以确定仿制药及其创新药的互换性。
24名健康参与者在禁食条件下接受单次口服剂量的两片20毫克辛伐他汀片，采用随机、开放标签、盲终点分析、双向交叉研究，洗脱期为一周。给药后24小时内进行药代动力学血样采集。采用液相色谱-串联质谱法并使用经过验证的方法测定辛伐他汀。最大血浆浓度（C）和从时间零到24小时最后观察到的浓度的血浆浓度-时间曲线下面积（AUC）的几何平均比值用于生物等效性评价。
所有24名参与者，12名男性和12名女性，均完成了研究。平均年龄为24.21岁，平均体重为58.81千克，平均体重指数为2
