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Trial record 35 of 39 for:    FLUMAZENIL

A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03444480
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Remimazolam Tosylate Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ⅰb Study Evaluating the Pharmacokinetic,Safety and Efficacy of Remimazolam Tosylate in Healthy Volunteers
Actual Study Start Date : July 23, 2014
Actual Primary Completion Date : August 16, 2014
Actual Study Completion Date : August 16, 2014

Arm Intervention/treatment
Experimental: Remimazolam Tosylate 1
IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start, 0.5 mg Flumazenil is administered
Drug: Remimazolam Tosylate
Initial dose plus supplemental doses
Other Name: HR7056

Experimental: Remimazolam Tosylate 2
IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start time,0.5ml placebo is administered
Drug: Remimazolam Tosylate
Initial dose plus supplemental doses
Other Name: HR7056




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of Remimazolam in human plasma. [ Time Frame: From prior to study drug injection until 4 hours post-dose ]
  2. Area under the plasma concentration versus time curve (AUC) of Remimazolam in human plasma. [ Time Frame: From prior to study drug injection until 4 hours post-dose ]
  3. Peak Plasma Concentration (Cmax) of M01 in human plasma. [ Time Frame: From prior to study drug injection until 4 hours post-dose ]
    M01 is the main metabolite of Remimazolam

  4. Area under the plasma concentration versus time curve (AUC) of M01 in human plasma. [ Time Frame: From prior to study drug injection until 4 hours post-dose ]
    M01 is the main metabolite of Remimazolam


Secondary Outcome Measures :
  1. Safety by measurement of Adverse Events. [ Time Frame: From start of study drug injection to patient discharge (approx. 2 days) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444480


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Pei Hu Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03444480     History of Changes
Other Study ID Numbers: RMZL-PIb
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018