drugset / Trial / NCT04463173

Food Effect Study of Anaprazole in Healthy Chinese Subjects

NCT04463173

Phase 1 Completed 14 enrolled Sihuan Pharmaceutical Holdings Group Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.

Timeline

Start
2015-06-16
Primary completion
2015-07-02
Completion
2015-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Anaprazole Other / unclassified 40 mg Oral

Indications

No indication recorded.