NCT04463173

Food Effect Study of Anaprazole in Healthy Chinese Subjects

A Single-center, Randomized, Open-labeled, Crossover Phase 1 Study to Evaluate the Pharmakinetics Effect of High Fat Food to Single Dose Administration of Anaprazole in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Anaprazole	single dose, oral administration 30 minutes after breakfast with high fat food.
DRUG	Anaprazole	single dose, oral administration before breakfast.

Timeline

• Start date: 2015-06-16
• Primary completion: 2015-07-02
• Completion: 2015-07-02
• First posted: 2020-07-09
• Last updated: 2020-07-09