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NCT Number: NCT02233972

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

Ginkgolides Meglumine Injection

Drug

Placebo

Drug

Primary outcomes

  1. Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.

    Time frame: Day 1 and Day 22

  2. Pharmacokinetics parameters:AUC0-24h(Day 22/ Day 1)、Cmax(Day 22/ Day 1)for Midazolam.

    Time frame: Day 1 and Day 22

  3. Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.

    Time frame: Day 8

  4. Pharmacokinetics parameters:T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.

    Time frame: Day 19 and Day22

  5. Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.

    Time frame: 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.

    Time frame: Day 0, Day 1, Day 8-22 and Day 23

    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

Sponsors and collaborators

Lead sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Sep 9, 2014
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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