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出境医 / 临床实验 / Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

Study Description
Brief Summary:
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

Condition or disease Intervention/treatment Phase
AD Drug: Donepezil Pamoate for Injection 17mg Drug: Donepezil Pamoate for Injection 34mg Drug: Donepezil Hydrochloride 5mg Phase 1

Detailed Description:
The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects
Actual Study Start Date : July 2, 2019
Actual Primary Completion Date : August 6, 2020
Actual Study Completion Date : September 11, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: experimental group 1
HHT201 17mg injection
 Drug: Donepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
Other Name: HHT201
Experimental: experimental group 2
HHT201 34mg injection
 Drug: Donepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
Other Name: HHT201
Active Comparator: experimental group 3
Donepezil Hydrochloride oral tablet 5mg
 Drug: Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Other Name: Aricept
Outcome Measures
Primary Outcome Measures :
  1. Cmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Maximum observed concentration of drug substance in plasma.

  2. Tmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Time when the maximum concentration is acheived

  3. AUClast of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Area under the concentration-time curve from time zero to time of last measurable concentration.

  4. AUC0-∞ of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Area under the concentration-time curve from time zero to infinity.

  5. t1/2 of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    The time when the concentraion of the drug eliminated to half of the initial.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese healthy subjects, male or female
  • between the ages of 20 and 60 years
  • A body mass index (BMI), calculated as weight in kg/(height in m)², from 19 to 28 kg/m², and female weight≥45kg, male weight≥50kg
  • Able to provide written informed consent forms

Exclusion Criteria:

  1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
  2. Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg
  3. ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
  4. Clinically significant ECG abnormalities in screening or baseline, such as male QTc interval ≥450ms and female QTc interval ≥470ms, and were considered inappropriate for inclusion by the researchers
  5. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
  6. History or presence of drug or alcohol abuse
  7. Positive pregnancy test result, or plan to be pregnant if female
  8. An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing
  9. Participation in any other investigational drug trial within 30 days prior to screening.
Contacts and Locations

Locations
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China, Shanghai
Shanghai mental health center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Investigators
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Principal Investigator: Huafang Li, PhD Shanghai Mental Health Center
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE July 2, 2019
Actual Primary Completion Date August 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Cmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Maximum observed concentration of drug substance in plasma.
  • Tmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Time when the maximum concentration is acheived
  • AUClast of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Area under the concentration-time curve from time zero to time of last measurable concentration.
  • AUC0-∞ of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Area under the concentration-time curve from time zero to infinity.
  • t1/2 of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    The time when the concentraion of the drug eliminated to half of the initial.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • AUC of Donepezil [ Time Frame: Blood samples collected over a 29 days period ]
    Area under the concentration-time curve from time zero to time of last measurable concentration
  • Cmax of Donepezil [ Time Frame: Blood samples collected over a 29 days period ]
    Maximum observed concentration of drug substance in plasma
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects
Official Title  ICMJE Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects
Brief Summary The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
Detailed Description The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE AD
Intervention  ICMJE
  • Drug: Donepezil Pamoate for Injection 17mg
    A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
    Other Name: HHT201
  • Drug: Donepezil Pamoate for Injection 34mg
    A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
    Other Name: HHT201
  • Drug: Donepezil Hydrochloride 5mg
    A tablet of 5mg Donepezil Hydrochloride will be administered once.
    Other Name: Aricept
Study Arms  ICMJE
  • Experimental: experimental group 1
    HHT201 17mg injection
    Intervention: Drug: Donepezil Pamoate for Injection 17mg
  • Experimental: experimental group 2
    HHT201 34mg injection
    Intervention: Drug: Donepezil Pamoate for Injection 34mg
  • Active Comparator: experimental group 3
    Donepezil Hydrochloride oral tablet 5mg
    Intervention: Drug: Donepezil Hydrochloride 5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2020) 		38
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2019) 		18
Actual Study Completion Date  ICMJE September 11, 2020
Actual Primary Completion Date August 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chinese healthy subjects, male or female
  • between the ages of 20 and 60 years
  • A body mass index (BMI), calculated as weight in kg/(height in m)², from 19 to 28 kg/m², and female weight≥45kg, male weight≥50kg
  • Able to provide written informed consent forms

Exclusion Criteria:

  1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
  2. Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg
  3. ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
  4. Clinically significant ECG abnormalities in screening or baseline, such as male QTc interval ≥450ms and female QTc interval ≥470ms, and were considered inappropriate for inclusion by the researchers
  5. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
  6. History or presence of drug or alcohol abuse
  7. Positive pregnancy test result, or plan to be pregnant if female
  8. An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing
  9. Participation in any other investigational drug trial within 30 days prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932916
Other Study ID Numbers  ICMJE DON101-CTP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Huahai Pharmaceutical Co., Ltd. ( Shanghai Synergy Pharmaceutical Sciences Co., Ltd. )
Study Sponsor  ICMJE Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huafang Li, PhD Shanghai Mental Health Center
PRS Account Zhejiang Huahai Pharmaceutical Co., Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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