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drugset / Trial / NCT03458650

A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.

NCT03458650 ↗

Phase 1 Completed 38 enrolled Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
RandomizedFactorialQuadruple-blindTreatment

Summary

"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200 mg and multiple oral doses of 100 mg of LXI-15028.

Timeline

Start
2018-03-19
Primary completion
2018-04-23
Completion
2018-05-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tegoprazan Other / unclassified 50 mg Oral
Subject Tegoprazan Other / unclassified 100 mg Oral
Subject Tegoprazan Other / unclassified 200 mg Oral

Indications

No indication recorded.