A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

NCT02264535 | Completed Phase 4

• 1 other identifier: Z-YXPU-ZS-IV4
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Keywords

Allergy; Skin test; Ginkgolides Meglumine Injection

Outcome Measures

Primary Outcomes (2)

• The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection.

  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.

  15-20 minutes after intradermal tests.

Secondary Outcomes (2)

• 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.

Study Arms (3)

0.1mg/ml Ginkgolides Meglumine Injection

EXPERIMENTAL

Injection, 0.1mg/ml.

Drug: 0.1mg/ml Ginkgolides Meglumine Injection

1mg/ml Ginkgolides Meglumine Injection

EXPERIMENTAL

Injection, 1mg/ml.

Drug: 1mg/ml Ginkgolides Meglumine Injection

5mg/ml Ginkgolides Meglumine Injection

EXPERIMENTAL

Injection, 5mg/ml.

Drug: 5mg/ml Ginkgolides Meglumine Injection

Interventions

0.1mg/ml Ginkgolides Meglumine Injection DRUG

0.1mg/ml Ginkgolides Meglumine Injection

1mg/ml Ginkgolides Meglumine Injection DRUG

1mg/ml Ginkgolides Meglumine Injection

5mg/ml Ginkgolides Meglumine Injection DRUG

5mg/ml Ginkgolides Meglumine Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead
• Beijing Bionovo Medicine Development Co., Ltd.: collaborator

Study Sites (1)

Second Affiliated Hospital of Tianjin University of TCM

Tianjin, 300150, China

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Yuhong Huang

  Second Affiliated Hospital of Tianjin University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: October 15, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-04

Locations

CN (1)