NCT02264535

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

A Pilot Study for Ginkgolides Meglumine Injection Skin Testing

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This pilot study is designed to explore the optimal concentration and method of Ginkgolides Meglumine Injection skin testing and to evaluate the value of skin test in predicting any possible allergic reactions to Ginkgolides Meglumine Injection.

Detailed description

Subjects will be enrolled in one of three groups with different doses to receive skin prick testing. Then they may be arranged to receive intradermal, subcutaneous injection or intravenous tests with different doses.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	0.1mg/ml Ginkgolides Meglumine Injection
DRUG	1mg/ml Ginkgolides Meglumine Injection
DRUG	5mg/ml Ginkgolides Meglumine Injection

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• First posted: 2014-10-15
• Last updated: 2014-12-02

Locations

1 site across 1 country: China