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drugset / Trial / NCT04466748

A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects

NCT04466748 ↗

Phase 1 Completed 36 enrolled Sihuan Pharmaceutical Holdings Group Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36 subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2 subjects take placebo.

Timeline

Start
2015-09-08
Primary completion
2015-12-29
Completion
2015-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Anaprazole Other / unclassified 20 mg Oral
Subject Anaprazole Other / unclassified 40 mg Oral

Indications

No indication recorded.