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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: placebo; Drug: Midazolam; Drug: Ginkgolides Meglumine Injection

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midazolam and Ginkgolides Meglumine Injection; Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.	Drug: Midazolam; Drug: Ginkgolides Meglumine Injection
Placebo Comparator: Midazolam and placebo; Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.	Drug: placebo; Drug: Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.	Day 1 and Day 22
Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.	Day 1 and Day 22
Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.	Day 8
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
Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.	Day 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Ou Ning, First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Ginkgolides Meglumine Injection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: Z-YXPU-ZS-IV5