Uric acid renal calculus

The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels.

研究健康受试者在空腹及餐后条件下，单次口服由广州新济药业科技有限公司提供、澳美制药（海南）有限公司生产的别嘌醇片（受试制剂T，规格：300mg）与相同条件下单次口服由Aspen Pharma Trading Limited.持证的别嘌醇片（参比制剂R，商品名：Zyloric®，规格：300mg）的药动学特征，比较两制剂间药动学参数AUC 和Cmax 的差异，初步评估受试制剂与参比制剂吸收动力学的一致性。

本试验旨在以中国健康受试者为试验对象，采用自身交叉对照的试验设计，单次空腹和餐后口服江苏德源药业股份有限公司研制生产的别嘌醇片（规格：0.1 g），以Aspen Pharma Trading Limited持证、Aspen Bad Oldesloe GmbH生产的别嘌醇片（商品名：Zyloric ®）为参比制剂，比较两制剂的药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察受试制剂和参比制剂在中国健康受试者中的安全性。