Status:
COMPLETED
A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam
Lead Sponsor:
Jiangsu Kanion Pharmaceutical Co., Ltd
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-40 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02233972
Start Date
August 1 2014
Last Update
October 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029