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The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
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.
Details
| Lead sponsor | Guangzhou Yipinhong Pharmaceutical CO.,LTD |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2010-03 |
| Completion | 2010-12 |
Conditions
- Cardiovascular Diseases
Interventions
- Alprostadil Liposomes for Injection
Primary outcomes
- Safety assessment of Alprostadil Liposome for Injection — 14 days
The safety assessment for this study include: 1. Adverse event(AEs) 2. Change from baseline in physical examination,vital signs,laboratory examinations 3. Local irritation symptoms
Countries
China