HIV/AIDS
Conditions
Interventions
Group 1:Picika Oral Solution 60ml
Group 2:Picika Oral Solution 90ml
Group 3:Picika Oral Solution 120ml
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years, both male and female; 2. Men who weigh >= 50 kg and women >= 45 kg and body mass index (BMI): 19.0 to 26.0 kg/m^2, (including boundary values, BMI = weight/height 2); 3. During the screening period, the results of vital signs examination, physical examination, clinical laboratory examination, 12-lead electrocardiogram and chest CT examination are normal or the abnormality has no clinical significance as judged by the investigator; 4. Female subjects have not had unprotected sex within two weeks before screening; male subjects (or their partners) or female subjects have no reproductive plans or donations throughout the trial period and within 3 months after the end of the study Sperm and egg donation programs and the ability to take effective contraceptive measures; 5. Be able to communicate well with the researcher, understand and comply with the requirements of this study, participate voluntarily, and voluntarily sign the informed consent form before the start of any research procedure.
Exclusion criteria
Exclusion criteria: 1. Clinically significant history of drug allergy, atopic allergic disease (such as urticaria, rash, asthma, angioedema, etc.), or known or suspected history of allergy to the test drug or its excipients; 2. Those who plan to undergo surgery within 4 weeks before screening or during the trial; 3. Pregnant and lactating women, or female subjects with positive blood pregnancy test; 4. Those who have used any drugs or health products within 4 weeks before screening; those who have used any drugs or health products within 1 week before the first administration of the test drug. (including: prescription drugs, over-the-counter drugs, vitamin supplements and Chinese herbal medicines, etc.); 5. Those who have participated in clinical trials of other drugs/devices within 3 months before screening; 6. Those who have been vaccinated within 4 weeks before screening; 7. Those who lost or donated blood >=400 mL within 3 months before screening, or who received blood transfusion or used blood products; 8. Drinking more than 14 standard units per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) per week within 6 months before screening, or before taking the drug for the first time Drinking alcohol within 48 hours, or the result of alcohol breath test is greater than 0.0 mg/100 mL, or those who cannot interrupt drinking during the test; 9. Those who smoked more than 5 cigarettes per day within 3 months before screening, or who could not stop using any tobacco products during the trial; 10. Those who have a history of drug abuse within 12 months before screening, those who have used drugs within 3 months before screening, or those with positive urine drug test; 11. Drinking excessive caffeinated beverages (more than 8 cups a day, 1 cup = 250 mL) within 6 months before screening, or ingesting any food or beverage containing caffeine within 48 hours before the first dose of the test (such as: coffee, tea, cola, soda, chocolate, etc.), or the test period cannot be interrupted; 12. Those who have ingested star fruit, papaya, dragon fruit, grapefruit or their products within 48 hours before the first administration of the test drug, or cannot be interrupted during the test; 13. Significant changes in diet or exercise habits (such as dieting, overeating, etc.) within 3 months before screening, or strenuous exercise within 48 hours before administration; 14. Those who have special requirements for diet and cannot comply with the unified diet [such as standard meal food intolerance, lactose intolerance, etc.] or those who have difficulty swallowing; 15. Those who are dizzy with needles, faint with blood, cannot tolerate venipuncture or have difficulty in collecting blood; 16. Subjects judged by other investigators to be inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Sign monitoring;Physical Examination;Laboratory Testing;Pharmacokinetic parameters;Adverse Event;ECG; | — |
Countries
China
Contacts
Public ContactZhang Shifu
Beijing Deyitang Health Science Co.,Ltd.
Outcome results
None listed