A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

Jiangsu Kanion Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Allergy

Treatments: Drug: 0.1mg/ml Ginkgolides Meglumine Injection; Drug: 1mg/ml Ginkgolides Meglumine Injection; Drug: 5mg/ml Ginkgolides Meglumine Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02264535

Z-YXPU-ZS-IV4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 3 patient groups

0.1mg/ml Ginkgolides Meglumine Injection

Experimental group

Description:

Injection, 0.1mg/ml.

Treatment:

Drug: 0.1mg/ml Ginkgolides Meglumine Injection

1mg/ml Ginkgolides Meglumine Injection

Experimental group

Description:

Injection, 1mg/ml.

Treatment:

Drug: 1mg/ml Ginkgolides Meglumine Injection

5mg/ml Ginkgolides Meglumine Injection

Experimental group

Description:

Injection, 5mg/ml.

Treatment:

Drug: 5mg/ml Ginkgolides Meglumine Injection