Status:
COMPLETED
A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Anesthesia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
Detailed Description
1. Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen. 2. Study the reversal effect and time required of Flumazepine on Ri...
Eligibility Criteria
Inclusion
- Aged ≥18 and ≤55 years.
- Weight range 50 to 100 kg and body mass index (BMI) 18 to 26 kg/m2.
- Willing and able to comply with the requirements of the protocol.
- Provide written informed consent to participate in the study.
Exclusion
- Abnormal results of physical or laboratory examination with clinical significance
- With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV).
- With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor.
- Subject with clinically significant abnormalities in baseline 12-lead electrocardiogram (ECG) or vital signs（SBP \<90 mmHg or \>140 mmHg，DBP \<50 mmHg or \>90 mmHg；Hr \<50 bpm or \>100 bpm；SpO2 \<95%）.
- Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated.
- Receipt of other medication within 14 days of the first study day.
- Blood donation greater than 200 ml or participation in a clinical study of an unlicensed drug in the previous 3 months.
- History of smoking or alcohol abuse within 6 months of screening.
- History of grapefruit juice or any other foods affect the activity of cytochrome P450 3A4（CYP3A4） within 7 days of screening.
- Pregnant,lactating.
- Mallampati score ≥3.
- Patients who in the opinion of the investigator may not be able to comply with the requirements of the study are not eligible
Key Trial Info
Start Date :
July 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03444480
Start Date
July 23 2014
End Date
August 16 2014
Last Update
February 23 2018
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032