Clinical trial NCT02233972: A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam
Official title: A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacokinetics
Keywords: Pharmacokinetics
Ginkgolides Meglumine Injection
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.
timeFrame: Day 1 and Day 22
measure: Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.
timeFrame: Day 1 and Day 22
measure: Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.
timeFrame: Day 8
measure: Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.
timeFrame: Day 19 and Day22
measure: Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.
timeFrame: Day 19
Secondary outcomes:
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.
timeFrame: Day 0, Day 1, Day 8-22 and Day 23
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
name: Ou Ning
role: PRINCIPAL_INVESTIGATOR
References: