A Pilot Study for Ginkgolides Meglumine Injection Skin Testing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
0.1mg/ml Ginkgolides Meglumine Injection
Injection, 0.1mg/ml.
干预措施: 0.1mg/ml Ginkgolides Meglumine Injection (Drug)
1mg/ml Ginkgolides Meglumine Injection
Injection, 1mg/ml.
干预措施: 1mg/ml Ginkgolides Meglumine Injection (Drug)
5mg/ml Ginkgolides Meglumine Injection
Injection, 5mg/ml.
干预措施: 5mg/ml Ginkgolides Meglumine Injection (Drug)
结局指标
主要结局
The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.
时间窗: 15-20 minutes after skin prick tests.
The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection.
时间窗: 15-20 minutes after intradermal tests.
次要结局
- The specificity and sensitivity with the different doses.(15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test.)
- Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests.(within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it.)