AD
Conditions
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.
Interventions
DRUGDonepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
DRUGDonepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
DRUGDonepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Sponsors
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Donepezil | Blood samples collected over a 35 days period | Maximum observed concentration of drug substance in plasma. |
| Tmax of Donepezil | Blood samples collected over a 35 days period | Time when the maximum concentration is acheived |
| AUClast of Donepezil | 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 | Blood samples collected over a 35 days period | Area under the concentration-time curve from time zero to infinity. |
| t1/2 of Donepezil | Blood samples collected over a 35 days period | The time when the concentraion of the drug eliminated to half of the initial. |
Countries
China
Outcome results
None listed