NCT02889822

The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. 1. Single dosing tolerability test in humans.There are 7 dose (10ug,20ug,50ug,100ug,200ug,300ug,400ug) groups in the single dosing tolerance test in healthy adult volunteers.The beginning dose of the study is 10ug,according to the dose escalation method,subjects who have successfully completed previous dose group and passed the safety assessment will enter the test of next dose group with the same method. 2. Multiple dosing tolerability test in humans.Choose the proper dosage for multiple dosing tolerance test based on the single-dose tolerance test result.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2016-09-07
• Last updated: 2016-09-13

Locations

1 site across 1 country: China