Status:
COMPLETED
A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.
Lead Sponsor:
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborating Sponsors:
Beijing Bionovo Medicine Development Co., Ltd.
Conditions:
Allergy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- Male and female between the ages of 18 and 70(inclusive)at the time of signing the Informed Consent Form （ICF）.
- Subjects meet any one of the following requirements
- No history of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
- History of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection), and no allergy.
- History of allergy to any dugs contain bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
- History of allergy to any other drugs.
- Willingness to participate in the study as evidenced by signing the informed consent form.
Exclusion
- Women in breastfeeding,menstrual or pregnancy period.
- Subjects are in the infectious disease, eczema, dermatitis, trauma,etc.
- Subjects meet any one of the following conditions
- Used β-blockers within 2 days prior to starting this study.
- Used H1 anti-histamines, imipramine, phenothiazine, Beta adrenaline etc. within 1 week prior to starting this study.
- Used short-acting glucocorticoids drugs within 1 week prior to starting this study.
- Topical used glucocorticoids drugs within 2 weeks prior to starting this study.
- Used long-acting glucocorticoids drugs within 4 weeks prior to starting this study
- Subjects are currently participating or have participated in any other clinical trials within the prior 1 month of signing the ICF.
- Subjects have a history of allergic shock.
- Subjects who are not suitable for this clinical trial at the discretion of the investigator.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02264535
Start Date
June 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Second Affiliated Hospital of Tianjin University of TCM
Tianjin, China, 300150