None
Conditions
Interventions
RT group (fasting):50mg of the reference formulation (R) followed by 50mg of the test formulation (T)
TR group (fed):50 mg of the subject formulation (T) followed by 50 mg of the reference formulation (R)
TR group (fasting):50 mg of the subject formulation (T) followed by 50 mg of the reference formulation (R)
RT group (fed):50mg of the reference formulation (R) followed by 50mg of the test formulation (T)
Sponsors
The Fifth Affiliated Hospital of 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, and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form personally before any research procedures begin, ensuring participation throughout the entire trial; 2. Healthy male or female aged 18 years or older (including 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 boundary values, BMI = weight (kg) / height^2 (m^2)); 4. Voluntarily take effective contraception within 3 months from screening to the end of the trial (including the subject's partner), and have no plans for pregnancy, sperm donation, or egg donation in the next 3 months; 5. Commit to having no history of mental disorders, be able to communicate well with the researchers, and understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to minocycline or formulation excipients, or who have known hypersensitivity to any drug, food, etc., or who have a history of atopic allergic reactions (e.g., asthma, rubella, eczematous dermatitis) or who are severe allergic sensitizers that, in the judgment of the investigator, are clinically significant; 2. Those with a history of dysphagia or any gastrointestinal disorder that interferes with drug absorption; 3. History of any chronic or serious disease of any circulatory, digestive, urinary, respiratory, neurologic, immune, endocrine, or psychiatric abnormality, or any other disease that may interfere with the test results, or history of prior major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterotomy, gastric bypass, gastric division or gastric cystic banding, cholecystectomy , with the exception of appendicitis surgery and prolapse surgery), or any history of surgery within 3 months prior to screening, trauma that may affect the safety of the trial or the in vivo course of the drug, or surgery during the planned study; 4. Those with a history of blood or needle sickness or those who cannot tolerate venipuncture; 5. Persons with a history of substance abuse within 6 months prior to screening, or persons who have used drugs within 3 months prior to screening, including repeated and heavy use of all types of narcotic drugs and psychotropic substances for non-medical purposes; 6. Those who have participated or are participating in other clinical trials of drugs or medical devices in the 3 months prior to screening and who have utilized a trial drug or medical device intervention; 7. Those who have donated blood including blood components or significant blood loss (=400mL) within 3 months prior to screening, or who have received a blood transfusion or used blood products, or who plan to donate blood (including blood components) during the trial or within 3 months after the trial is completed; 8. Those who have used any prescription drugs, over-the-counter drugs, herbs and vitamins within 28 days prior to screening; 9. Use of any drug that interacts with minocycline within 3 months prior to screening [e.g., calcium, magnesium, aluminum, lanthanum, iron, anticoagulants, lipid-lowering drugs such as colestipol or colestipol, general anesthetics methoflurane, penicillins, strong diuretics (e.g., furosemide, etc.), other hepatotoxic drugs (e.g., antitumor chemotherapeutic agents), ergot alkaloids, isotretinoin, or other systemic classes of retinoids or vitamin A etc.] persons; 10. Those who have been vaccinated within 3 months prior to screening or who plan to be vaccinated during the trial; 11. Those who smoked greater than or equal to 5 cigarettes per day in the 3 months prior to screening, or who were unable to stop using any tobacco-based products during the trial; 12. Those whose alcohol intake averaged more than 2 units per day (1 unit = 360mL of beer, or 150mL of wine, or 45mL of distilled spirits) in the 3 months prior to screening, or who did not agree to avoid alcohol during the trial; 13. Excessive daily consumption of strong tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) in the 3 months prior to screening; 14. Those who cannot guarantee that they will abstain from eating strong tea, chocolate, coffee or food or drinks containing caffeine, alcohol, xanthines (such as anchovies, sardines, beef liver, beef kidney, etc.), grapefruit (juic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of minocycline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events, adverse reactions, and serious adverse events; | — |
Countries
China
Contacts
Public ContactZheng Sichao
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed