[Translation] A single-dose, randomized, open-label, three-period, three-sequence, partially repeated crossover bioequivalence study of ritodrine hydrochloride (ritodrine, 10 mg, oral tablet) and Utemerin® (ritodrine, 5 mg, oral tablet) in healthy adult female subjects under fed conditions
主要研究目的
在健康成年女性受试者中于餐后情况下评价盐酸利托君片和Utemerin®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的
评估受试制剂盐酸利托君片和参比制剂Utemerin®在健康成年女性受试者中的安全性。
[Translation] Primary study objective
To evaluate the absorption rate and extent of ritodrine hydrochloride tablets and Utemerin® in healthy adult female subjects after meals, and to evaluate whether the two preparations are bioequivalent.
Secondary study objective
To evaluate the safety of the test preparation ritodrine hydrochloride tablets and the reference preparation Utemerin® in healthy adult female subjects.