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

NCT02233972 | Completed Phase 4

• 1 other identifier: Z-YXPU-ZS-IV5
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Pharmacokinetics; Ginkgolides Meglumine Injection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.

  Day 0, Day 1, Day 8-22 and Day 23

Study Arms (2)

Midazolam and Ginkgolides Meglumine Injection

EXPERIMENTAL

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

Midazolam and placebo

PLACEBO COMPARATOR

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: Midazolam; Drug: placebo

Interventions

Midazolam DRUG

Midazolam and Ginkgolides Meglumine Injection; Midazolam and placebo

Ginkgolides Meglumine Injection DRUG

Midazolam and Ginkgolides Meglumine Injection

placebo DRUG

Midazolam and placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ou Ning

  First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Last Updated: October 20, 2014

Record last verified: 2014-08

Locations

CN (1)