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The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

NCT02889822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-09-13

No results posted yet for this study

Summary

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and tolerability of single/multiple-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

Conditions

Interventions

DRUG

Alprostadil Liposomes for Injection

1. Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd 2. Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days.

Sponsors & Collaborators

  • Guangzhou Yipinhong Pharmaceutical CO.,LTD

    lead INDUSTRY

Principal Investigators

  • Zeyuan Liu · The Affiliated Hospital of Academy of Military Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02889822 on ClinicalTrials.gov