Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

• Status: Completed
• Trial end date: 2020-09-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
• Treatments: Donepezil

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.