A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

Anesthesia Clinical Trial

Official title:

A Phase Ⅰb Study Evaluating the Pharmacokinetic,Safety and Efficacy of Remimazolam Tosylate in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444480
• Other study ID #: RMZL-PIb
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2015
• Last updated: February 22, 2018
• Start date: July 23, 2014
• Est. completion date: August 16, 2014

Study information

• Verified date: February 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Rimazolam'effect.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 16, 2014
• Est. primary completion date: August 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Remimazolam Tosylate
Initial dose plus supplemental doses

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of Remimazolam in human plasma.		From prior to study drug injection until 4 hours post-dose
Primary	Area under the plasma concentration versus time curve (AUC) of Remimazolam in human plasma.		From prior to study drug injection until 4 hours post-dose
Primary	Peak Plasma Concentration (Cmax) of M01 in human plasma.	M01 is the main metabolite of Remimazolam	From prior to study drug injection until 4 hours post-dose
Primary	Area under the plasma concentration versus time curve (AUC) of M01 in human plasma.	M01 is the main metabolite of Remimazolam	From prior to study drug injection until 4 hours post-dose
Secondary	Safety by measurement of Adverse Events.		From start of study drug injection to patient discharge (approx. 2 days)