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

NCT04467060 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-07-10

No results posted yet for this study

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

DRUG

Anaprazole Sodium

2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，fasting oral administration.

DRUG

Placebo

single dose, 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
2014-08-14
Primary Completion
2015-06-25
Completion
2015-06-25

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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 NCT04467060 on ClinicalTrials.gov