Bioequivalence Study in human
Conditions
Interventions
1:Phase 1: Entecavir Tab 1 mg (Beijing Baiao Pharmaceuticals Co., Ltd.)
Phase 2: Entecavir Tab 1 mg (Beijing Baiao Pharmaceuticals Co., Ltd.)
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male and female Chinese healthy volunteers, the rate of female and male was not less than 1:2 2) Male and female aged more than 18 years; 3) Male subjects weight greater than 50 kg, the female subjects weight greater than 45 kg, BMI 19 to 28; 4) Subjects are in good healthy condition, without abnormalities in heart, liver, kidney, digestive system, respiratory system, nervous system and mental disorders, metabolic abnormalities and other medical history; 5) Subjects have the ability to communicate with the health care workers and comply with the relevant hospital regulations; 6) Subjects are able to communicate with the researchers, understand and comply with research requirements; 7) All subjects are voluntary to take part in the trial and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests(clinical significance after clinician judgment); 2. History or abnormalities of cardiovascular, endocrine, psychological, respiratory, haematological, immune and metabolic system ; 3. History of gastrointestinal diseases or surgery (except for appendicitis) with effect on drug absorption; 4. Hepatitis B surface antigen-positive or chronic hepatitis; 5. HIV or TP antibody positive, hepatitis C (HCV) antigen positive; 6. More than 5 cigarettes per day, suspected or confirmed drug abuse history; alcohol intake more than 2 units per day for 3 months (1 unit = 12 ounces or 360mL beer, 5 ounces or 150mL white wine, 1.5 ounces or 45mL distilled wine) or positive alcohol test; 7. Participate in other drug clinical trials or use the experimental drug during 3 months prior to enrollment ; 8. Prescription or over-the-counter medications has been used within two weeks prior to enrollment; 9. History of clinically significant allergic reactions or history of drug allergies, especially allergy to entecavir or any ingredients of entecavir; 10. Blood donation or blood loss equal to or more than 400 mL three months before the trial,or prepare to participate in blood donation during the trial or within three months after the trial; 11. Pregnant or breastfeeding women, or women of childbearing age without the use of acceptable contraceptive methods, or women of pregnancy test positive or have the plan of childbearing in the next six months; 12. The subject can not tolerate intravenous blood collection; 13. The subject can not follow limitations on smoking or grapefruit juice or any alcohol and xanthine-containing food and beverages (including chocolate, tea, coffee, cola, etc.) from the first 48 hours before the medication to the last blood collection; 14. Any other situation that the investigator think may affect the safety of subjects and judgment of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of Entecavir; | — |
Countries
China
Contacts
Public ContactRui Wang
Chinese PLA General Hospital
Outcome results
None listed