NCT04467060

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

A Single-center, Randomized, Double-blinded, Placebo Parallel Controlled Phase 1 Study to Evaluate the Safety and Pharmacology of Single Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• 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 Sodium	2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，fasting oral administration.
DRUG	Placebo	single dose, fasting oral administration

Timeline

• Start date: 2014-08-14
• Primary completion: 2015-06-25
• Completion: 2015-06-25
• First posted: 2020-07-10
• Last updated: 2020-07-10