/ Not yet recruitingPhase 3 比较尿素[13C]呼气试验药盒与原研产品-尿素[13C]呼气试验诊断试剂盒用于诊断Hp感染一致性的多中心、随机、双盲、原研交叉对照的III期临床研究
[Translation] A multicenter, randomized, double-blind, original cross-controlled phase III clinical study comparing the consistency of the urea [13C] breath test kit with the original product-urea [13C] breath test diagnostic kit for diagnosing Hp infection
主要目的
评价尿素[13C]呼气试验药盒与原研产品用于诊断Hp 感染的一致性。
次要目的
评价尿素[13C]呼气试验药盒用于诊断Hp 感染的有效性及安全性。
[Translation] Primary objective
To evaluate the consistency between the urea [13C] breath test kit and the original product in diagnosing Hp infection.
Secondary objective
To evaluate the effectiveness and safety of the urea [13C] breath test kit in diagnosing Hp infection.
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