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A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

NCT ID: NCT02264535

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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0.1mg/ml Ginkgolides Meglumine Injection

Injection, 0.1mg/ml.

Group Type EXPERIMENTAL

0.1mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

1mg/ml Ginkgolides Meglumine Injection

Injection, 1mg/ml.

Group Type EXPERIMENTAL

1mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

5mg/ml Ginkgolides Meglumine Injection

Injection, 5mg/ml.

Group Type EXPERIMENTAL

5mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

Interventions

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0.1mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

1mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

5mg/ml Ginkgolides Meglumine Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Bionovo Medicine Development Co., Ltd.

OTHER

Sponsor Role collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuhong Huang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Tianjin University of TCM

Locations

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Second Affiliated Hospital of Tianjin University of TCM

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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Z-YXPU-ZS-IV4

Identifier Type: -

Identifier Source: org_study_id