NCT04466748

A Multiple 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 Pharmacokinetics/Pharmacodynamics of Multiple Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Anaprazole Sodium enteric-coated tablet	Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.
DRUG	Placebo	Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.

Timeline

• Start date: 2015-09-08
• Primary completion: 2015-12-29
• Completion: 2015-12-29
• First posted: 2020-07-10
• Last updated: 2020-07-10