Viewing Study NCT02264535


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Study NCT ID: NCT02264535
Status: COMPLETED
Last Update Posted: 2014-12-02
First Post: 2014-09-04
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.
Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Organization:

Study Overview

Official Title: A Pilot Study for Ginkgolides Meglumine Injection Skin Testing
Status: COMPLETED
Status Verified Date: 2014-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: