HBV?HIV-1 infection
Conditions
Interventions
Phase 3 take test preparation after meal
Phase 4 take control product after meal.
Phase 3 take control product after meal
Phase 4 take test preparation after meal.
Sponsors
The first hospital of jilin university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between 18 and 45 years of age; 2. At least 55kg for male and 45kg for female, with a Body Mass Index (BMI) between 18.5-28kg/m2, inclusive(BMI = kg/m2); 3. Females of child bearing potential should use effective contraception for an appropriate period prior to the first dose and throughout the study treatment .They are either sexually inactive (abstinent >=30 days before the first dose) or using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study; surgical sterilization of the partner (vasectomy for 6 months minimum); Female subjects utilizing hormonal contraceptive must have used the same hormonal contraceptive method for at least 3 months prior to study dosing. Subject should use same method till to the end of the study; 4. Male subject should agree to use condom correctly and constantly, and ask his female partner to use one of the methods mentioned till the end of study; 5. Non-smokers or ex-smokers (An ex-smoker being defined as someone who completely stopped smoking for at least 12 months before Day 1 of this study); 6. To be able to understand and provide written informed consent and voluntary consent to participate in the study; 7. To be able to complete the study in compliance with the protocol.
Exclusion criteria
Exclusion criteria: 1. A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neuropsychic disease); 2. A history of hypersensitivity to tenofovir or any other component of Tenofovir Disoproxil Fumarate Tablets; 3. History of renal or liver disease; 4. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption; 5. Positive test result of HIV antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody; 6. Positive alcohol breath test; 7. Positive pregnancy test or female who is lactating. 8. A recent history of alcoholism ( 450 mL) within 56 days prior to the initial dose of study medication; 16. Use of any prescription drugs, herbal supplements within 14 days prior to receiving study drug; 17. Consumption of any beverages or food with abundant xanthine and any grapefruit or grapefruit-containing juices within 72 hours prior to receiving study drug; 18. Use of any over-the-counter (OTC) drugs other than vitamins within 48 hours prior to receiving study drug; 19. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 20. Consumption of alcohol within 48 hours prior to receive study drug; 21. Any condition which in the opinion of Investigator would interfere with the participants ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he or she took part in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of Tenofovir Disoproxil Fumarate Tablets; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety indicator; | — |
Countries
China
Contacts
Public ContactDing YanHua
Outcome results
None listed