A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Feb 22, 2018

Keywords

ClinConnect Summary

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 Rimazolam'effect.
3. Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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

Trial Officials