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A Multiple Ascending High Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects

NCT04471922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-07-15

No results posted yet for this study

Summary

A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (7 days) ascending dose (60mg QD, 80mg QD, 100mg Qd) administrationof Anaprazole in healthy Chinese subjects. 45 subjects, 15 subjects for each dose group. In each dose group, 10 subjects take investigational drug (anaprazole), 2 subjects take active comparatory drug (rabeprazole), 3 subjects take placebo.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Anaprazole Sodium enteric-coated tablet

Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 days, fasting oral administration.

DRUG

Placebo

Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.

DRUG

Active controlled (rabeprazole)

Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2019-03-28
Completion
2019-03-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471922 on ClinicalTrials.gov