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

Jiangsu Kanion Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Pharmacokinetics

Treatments: Drug: Ginkgolides Meglumine Injection; Drug: Midazolam; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02233972

Z-YXPU-ZS-IV5

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

Midazolam and Ginkgolides Meglumine Injection

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Drug: Ginkgolides Meglumine Injection

Midazolam and placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: Midazolam