None
Conditions
Interventions
R-T group:Fast-fasting administration test: During the first cycle, 6 participants in the test group took 1 tablet (0.4g) of the test formulation (T) orally on an empty stomach, swallowing it whole an
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, methods of the trial, as well as the possible adverse reactions. Voluntarily participate in the trial and sign the informed consent form by oneself before any research procedure begins, and ensure to be involved in the trial throughout the entire process. 2. Healthy male or female trial participants aged >= 18 years old. 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; body mass index (BMI) within the range of 19.0 - 26.0 kg/m^2 (including the critical value). 4. No abnormalities found in vital signs examination, physical examination, clinical laboratory tests (blood routine examination, urine dry chemical + urine sediment quantitative examination, blood biochemical examination, infection four-item examination, coagulation four-item examination), and 12-lead electrocardiogram examination. 5. All trial participants with reproductive capacity (including the partner of the trial participant) have no fertility plans from the time of signing the informed consent form until 3 months after the end of the trial and voluntarily take appropriate and effective contraceptive measures (Appendix 1), and have no plans for sperm donation or egg donation. 6. Able to communicate well with the researcher and be able to understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1.(Inspection, inquiry) Those who are known to be allergic to any drugs, foods, etc., or have a history of specific allergic reactions (such as asthma, measles, eczema), or are of a severe allergic constitution, and whose condition has been judged by the investigator to be clinically significant; as well as those who are known or suspected to be allergic to pentoxifylline or its excipients, or who are known to be allergic to methylxanthine drugs. 2.(Asking) Those who have difficulty in swallowing; 3.(Enquiry, Query) Individuals with a history of chronic diseases or serious illnesses as determined by the research doctor, which may include conditions such as circulatory system disorders, digestive system disorders, urinary system disorders, respiratory system disorders, nervous system disorders, immune system disorders, endocrine system disorders, mental abnormalities or metabolic abnormalities (e.g., known cerebral hemorrhage, extensive retinal hemorrhage, severe arrhythmia, acute myocardial infarction, etc.), or any other diseases that may interfere with the test results are eligible. 4.(Enquiry) Exclude those who have undergone surgeries that, based on the researcher's judgment, would affect the absorption, distribution, metabolism, and excretion of the drug; or those with a history of surgery within the past 3 months; or those who plan to undergo surgery during the study period or within one week after the study concludes. 5.(The) Vascular puncture conditions are poor. 6.(Enquiry) For those who cannot tolerate venipuncture, or those with a history of fainting or experiencing bleeding during injections; 7.(For inquiry and examination) Screen those who have a history of drug abuse within the past 6 months, or those who have used drugs within the past 3 months, including those who have repeatedly and in large quantities used various anesthetic drugs and psychotropic drugs for non-medical purposes, or those whose results of drug abuse screening (including: morphine, dimethylaminoamphetamine, methamphetamine, ketamine, tetrahydrocannabinolic acid) are positive for any one or more items. 8.(Inspection, network screening) Those who have participated in or are currently participating in other clinical trials within the past 3 months and have used the investigational drugs or medical devices for intervention. 9.(Enquiry) Those who have donated blood within the past 3 months, including whole blood or significant blood loss (>= 400 mL) (excluding physiological blood loss in women), have received blood transfusions or used blood products; or those who plan to donate blood (including blood components) within 3 months during the trial or after the trial is over. 10.(Inspection, examination) Women who are pregnant, breastfeeding, or had unprotected sexual intercourse within 14 days before the screening, or whose blood pregnancy test result was positive, or who used oral contraceptives within 30 days before the screening, or who used long-acting estrogen or progesterone injections (including progestin-type intrauterine devices) or implants within 6 months before the screening. 11.(For inquiry or query) Those who have used any prescription drugs, over-the-counter drugs, herbal medicines, health supplements or vitamins within the past 14 days; 12.(Enquiry) Those who have used any drugs that inhibit or induce the liver's metabolism of drugs within the past 30 days (such as inducers - barbiturates, carbamazepine, phenytoin, rifampicin, etc.; inhibitors -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the drug concentration-time curve from 0 to infinity (8);The area under the drug concentration-time curve from time 0 to the time t when the last measurable concentration was obtained;Peak concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decay rate constant;Half-life;Peak time; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed