Digestive system
Conditions
Interventions
Group 2:Zhejiang Yatai pharmaceutical Co., Ltd made doperidone suspension
Group 1:Kyowa Hakko Kirin made doperidone suspension
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, healthy male and female subjects; 2. Male subjects with weight=50kg, female subjects with weight =45kg; body mass index [BMI=weight (kg)/height(m)2] within the range of 19-26kg/m2; 3. subjects in healthy condition, without significant clinical symptoms or abnormal laborary test results of clinical significance; 4. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF; 5. Subject are able to proceed a smooth Communication with researchers, and a good compliance to the requirements of the study. subject are willing to say at Phase I study wards according to rules.
Exclusion criteria
Exclusion criteria: 1. subject cannot tolarate veinpunture; 2. Subject allergic to the study drug or its ingredients; subject has history of allergy or belongs to allergic constitution; 3. clinical history of ECG with previous clinical significance (e.g., male QTc>450ms and female QTc>470ms); Clinically relevant bradycardia; A family history of severe arrhythmia or symptomatic heart failure or long QT syndrome (grandparents, parents and siblings); 4. Subject has/had any history of serious disease, including but not limited to digestive, cardiovascular, respiratory, urinary, musculoskeletal, endorine, nervous, hemotologic, immune system or metabolic disorder; 5. patients with gastrointestinal dysfunction, biliary diseases, and urinary tract diseases, or have a history of digestive tract diseases affecting drug absorption; 6. labotory test: hemotology, urinalysis, blood biochemistry, chest X-ray, 12-lead ECG. Any of the above items is abnormal and determined clinical significant by researchers; 7. One of HbsAg, HCV antibody, HIV antibody, syphilis turn out to be positive; 8. Female subjects under pregenancy, lactation, or cannot take conspective measures; 9. positive pregnancy test; 10. male subjects fail to take effective contraceptive measures or their spouses plan to give birth within six months; 11. mentally or legally disabled; 12. screening those with a history of prescription drug abuse and/or illegal drug abuse within the first 6 months; 13. subject took over 5 cigarettes every day in the past 12 months, or cannot quit smoking during the study; subject drank frequently in the past 6 months, namely 14 unit alcohol every week (1 unit =360ml beer with 5% alcohol, 45ml liquor with 40% alcohol, 150 ml wine with 12% alcohol); 14. drug abuse test or alcohol test or nicotine test positive; 15. patients with a history of hospitalization or surgery (except for appendicitis) within the first 3 months; 16. those with a history of blood donation or acute blood loss in the first 2 months (400 mL) or who intend to donate blood within 1 month after the end of the test were screened; 17. select those who have participated in other drug clinical trials within the first 3 months; 18. subject had vaccination, any prescription or Chinese herbal medicine 4 weeks prior to first administration; subject took any OTC, food suppliment(including vitamin) 2 weeks prior to first administration; 19. subject refuses to stop any food or revee with methylxanthine, such as caffeine (coffee, tea, coke, choclate)from 2 days before to the end of the study; 20. those with special dietary requirements who cannot accept the unified diet; 21. those with lactose intolerance (those who have had milk diarrhea); 22. subject insuitable to the study according to researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax; | — |
Countries
China
Contacts
Public ContactWu Lihua
The First Affiliated Hospital, Zhejiang University
Outcome results
None listed