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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

Clinicaltrials.gov identifier NCT03932916

Recruitment Status Completed

First Posted May 1, 2019

Last update posted September 29, 2020

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:AD
  • Intervention/Treatment: Drug: Donepezil Pamoate for Injection 17mg
    Drug: Donepezil Pamoate for Injection 34mg
    Drug: Donepezil Hydrochloride 5mg
  • Phase: 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
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: August 2020
  • Actual Study Completion Date: September 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.
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.
Active Comparator: experimental group 3
Donepezil Hydrochloride oral tablet 5mg
Drug: Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. AUC0-∞ of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Area under the concentration-time curve from time zero to infinity.
  • 3. Cmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Maximum observed concentration of drug substance in plasma.
  • 4. Tmax of Donepezil [ Time Frame: Blood samples collected over a 35 days period ]
    Time when the maximum concentration is acheived
  • 5. 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.
Eligibility Criteria
  • Ages Eligible for Study: 20 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 100/min; Sitting systolic blood pressure 140mmHg, diastolic blood pressure 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
Contacts
Locations

China, Shanghai
Shanghai mental health center
Shanghai

Sponsors and Collaborators

Shanghai Synergy Pharmaceutical Sciences Co., Ltd.

Investigators

Principal Investigator: Huafang Li, PhD Shanghai Mental Health Center

More Information
  • Responsible Party: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03932916 History of Changes
  • Other Study ID Numbers: DON101-CTP
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: September 29, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No