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drugset / Trial / NCT04467060

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

NCT04467060 ↗

Phase 1 Completed 74 enrolled Sihuan Pharmaceutical Holdings Group Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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
2014-08-14
Primary completion
2015-06-25
Completion
2015-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Anaprazole Other / unclassified 2.5 mg Oral
Subject Anaprazole Other / unclassified 5 mg Oral
Subject Anaprazole Other / unclassified 10 mg Oral
Subject Anaprazole Other / unclassified 20 mg Oral
Subject Anaprazole Other / unclassified 40 mg Oral
Subject Anaprazole Other / unclassified 80 mg Oral
Subject Anaprazole Other / unclassified 120 mg Oral
Subject Anaprazole Other / unclassified 160 mg Oral

Indications

No indication recorded.