A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam

Pharmacokinetics Clinical Trial

Official title:

A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233972
• Other study ID #: Z-YXPU-ZS-IV5
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2014
• Last updated: October 16, 2014
• Start date: August 2014

Study information

• Verified date: August 2014
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Ages 18-40.

• Male.

• Subjects have standard weight( generally not less than 50 kg), and body mass index (BMI) within 19-25.

• All physical examinations( including ECG, kidney function, liver function, blood routine, urine routines, etc) are normal.

• Subjects have no history of significant diseases, allergy or orthostatic hypotension.

• All subjects sign the informed consent after being informed all possible adverse drug reaction and .are able to complete all examination defined.

Exclusion Criteria:

• Subjects who cannot communicate with medical staff, and subjects with cerebral insufficiency or psychological problem.

• Partner of subjects have plan to pregnant.

• Subject have primary disease in vital organ.

• Subjects have a history of drug dependence or psychosis in last 2 years.

• Subjects with severe blood loss or blood donation more than 200 mL in the prior 3 months.

• Subjects who have participated in another clinical trial within the prior 3 months.

• Known or suspected to have a history of alcohol or drug abuse.

• Subjects who have abnormal clinical significance after checking preclinical laboratory data and physical examinations.

• Known allergy to pharmaceutical ingredient of Ginkgolides Meglumine Injection or allergy sufferers who are allergic to more than two kinds of food or drugs in the past.

• Subjects who have used any drugs in the prior 2 weeks.

• Subjects have unexplained infections.

• The subjects could not complete the study in the opinion of the Principal Investigator due to any reason.

• Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) , hepatitis B surface antigen (HbsAg), etc.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Midazolam

• Ginkgolides Meglumine Injection

• placebo

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters:Cmax?Tmax?AUC0-24h?T1/2?CL/F?Vz/F for Midazolam.		Day 1 and Day 22	No
Primary	Pharmacokinetics parameters:AUC0-24h(Day 22/ Day 1)?Cmax(Day 22/ Day 1)for Midazolam.		Day 1 and Day 22	No
Primary	Pharmacokinetics parameters:Cmax?Tmax?AUC0-24h?T1/2?CL/F?Vz/F for Ginkgolides Meglumine Injection.		Day 8	No
Primary	Pharmacokinetics parameters:T1/2?CL/F?Vz/F?Cmax,ss?Cmin,ss?Cav,ss?Tmax,ss?AUCtau,ss for Ginkgolides Meglumine Injection.		Day 19 and Day22	No
Primary	Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.		Day 19	No
Secondary	Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.	Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23	Day 0, Day 1, Day 8-22 and Day 23	Yes