Acute ischemic stroke
Conditions
Interventions
Experimental group:On days 1 and 6, take a single oral dose of Adefovir Dipivoxil Tablets. From day 4 to day 7, take XY03-EA Tablets every 8 hours.
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.The research participants must have given their informed consent for the trial before the experiment, fully understood the content, process and possible adverse reactions of the trial, and voluntarily signed a written informed consent form. 2. Male or female participants aged 18 to 45 years old (inclusive of the boundary values), who are healthy Chinese individuals; 3. Male participants had a body weight of 50 kg or more, female participants had a body weight of 45 kg or more, and their body mass index (BMI) was within the range of 18.0 to 26.0 kg/m2 (including the boundary values). BMI = weight (kg) / height (m2). 4. The research participants were able to communicate well with the researchers and were able to complete the trial in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1.People with allergic constitution, such as those allergic to two or more drugs, foods and pollen, and/or those with a known history of allergy to the components of the study drugs (XY03-EA tablets and Adefovir Dipivoxil tablets) or their excipients; 2. Those who have had or currently have cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, persistent rapid arrhythmia, torsade de pointes (Tdp) or ventricular tachycardia, a history of clinically significant T-wave changes, myocardial infarction, angina pectoris, QT prolongation syndrome, or have symptoms or a family history of long QT syndrome; 3. Any history of severe clinical diseases or conditions that the investigator believes may affect the trial results, including but not limited to neurological/spiritual systems, respiratory systems, cardiovascular systems, endocrine systems, urinary systems, hematological systems, immunological systems (including personal or family history of hereditary immune deficiencies), digestive systems (with history of difficulty in swallowing or any gastrointestinal diseases affecting drug absorption), malignant tumors, etc. 4. Have any diseases that increase the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers, etc. 5. Abnormal findings in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc., which have clinical significance as determined by the researchers; 6. Exclusion criteria: Those who have undergone major surgery within the past 6 months or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or incisional biopsies or obvious traumatic injuries, or those who plan to undergo surgery during the trial. 7. Exclude those who have used any drugs that inhibit or induce liver drug-metabolizing enzymes within the past 28 days (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, verapamil, macrolides, nitroimidazoles, sedative-hypnotics, fluoroquinolones, antihistamines). 8. Those who tested positive for drug abuse on the day of admission to the research institution; 9. Select those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the fact that the research participants received treatment with the trial drugs or medical devices). 10. Those with a history of drug abuse, and/or those who have used drugs within the previous 3 months before screening, and/or those who habitually use any drugs, including herbal preparations; 11. Those who test positive for any one of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV), human immunodeficiency virus (HIV) antibody, or syphilis antibody (TPPA) during the screening period will be included. 12. Select those who smoked an average of more than 5 cigarettes per day in the previous 3 months, or those who were unable to quit smoking during the trial. 13. Select individuals who have consumed alcohol frequently within the past three months, that is, those who have consumed more than 14 units of alcohol per week (1 unit = 10 mL of ethanol, which is equivalent to 1 unit = 200 mL of 5% alcohol beer, 25 mL of 40% alcohol spirits, or 83 mL of 12% alcohol wine) or those wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of adefovir dipivoxil tablets;Pharmacokinetic parameters of XY03-EA tablet; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators (blood routine, urine routine, blood biochemistry, coagulation function); | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed