Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects
NCT ID: NCT03932916
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2019-07-02
2020-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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experimental group 1
HHT201 17mg injection
Donepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
experimental group 2
HHT201 34mg injection
Donepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
experimental group 3
Donepezil Hydrochloride oral tablet 5mg
Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Interventions
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Donepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
Donepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
20 Years
59 Years
ALL
Yes
Sponsors
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Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Huafang Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Shanghai mental health center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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DON101-CTP
Identifier Type: -
Identifier Source: org_study_id
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