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CompletedNCT03932916Updated Sep 29, 2020

Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

A Phase 1 interventional study of Donepezil Pamoate for Injection 17mg and Donepezil Pamoate for Injection 34mg in AD, sponsored by Shanghai Synergy Pharmaceutical Sciences Co., Ltd.. Completed at 1 site in China. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
20 Years to 59 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

Read the 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.

02

Conditions studied

  • AD
03

In context

Lead sponsor

Shanghai Synergy Pharmaceutical Sciences Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    experimental group 1

    HHT201 17mg injection

    Drug: Donepezil Pamoate for Injection 17mg

  • Experimental
    experimental group 2

    HHT201 34mg injection

    Drug: Donepezil Pamoate for Injection 34mg

  • Active comparator
    experimental group 3

    Donepezil Hydrochloride oral tablet 5mg

    Drug: Donepezil Hydrochloride 5mg

Interventions

  • DrugDonepezil Pamoate for Injection 17mg

    A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.

    Also known as: HHT201

  • DrugDonepezil Pamoate for Injection 34mg

    A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.

    Also known as: HHT201

  • DrugDonepezil Hydrochloride 5mg

    A tablet of 5mg Donepezil Hydrochloride will be administered once.

    Also known as: Aricept

06

What researchers measure

Primary outcomes

  1. Cmax of Donepezil

    Maximum observed concentration of drug substance in plasma.

    Time frame: Blood samples collected over a 35 days period

  2. Tmax of Donepezil

    Time when the maximum concentration is acheived

    Time frame: Blood samples collected over a 35 days period

  3. AUClast of Donepezil

    Area under the concentration-time curve from time zero to time of last measurable concentration.

    Time frame: Blood samples collected over a 35 days period

  4. AUC0-∞ of Donepezil

    Area under the concentration-time curve from time zero to infinity.

    Time frame: Blood samples collected over a 35 days period

  5. t1/2 of Donepezil

    The time when the concentraion of the drug eliminated to half of the initial.

    Time frame: Blood samples collected over a 35 days period

07

Study locations

1 site
  • Shanghai mental health center
    Shanghai, Shanghai 200030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03932916
Lead sponsor
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Responsible party
Sponsor
First posted
May 1, 2019
Start date
Jul 2, 2019
Primary completion
Aug 6, 2020
Completion
Sep 11, 2020
Last update
Sep 29, 2020

Study contacts

Huafang Li, PhD
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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