None listed
Conditions
Interventions
RTRT fast group:Subjects received the reference formulation in Period 1 and the test formulation in Period 2, followed by the reference formulation again in Period 3 and the test formulation in Period
TRTR fast group:Subjects received the test formulation in Period 1 and the reference formulation in Period 2, followed by the test formulation again in Period 3 and the reference formulation in Period
RTRT fed group:Subjects received the reference formulation in Period 1 and the test formulation in Period 2, followed by the reference formulation again in Period 3 and the test formulation in Period
TRTR fed group:Subjects received the test formulation in Period 1 and the reference formulation in Period 2, followed by the test formulation again in Period 3 and the reference formulation in Period
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understood the purpose, nature, methods of the trial, and possible adverse reactions. They voluntarily participated in the study and signed the informed consent form before the initiation of any research procedures. 2. Healthy male and female subjects between 18 and 45 years of age, with a balanced gender ratio. 3. Male subjects with a body weight of at least 50.0 kg and female subjects with a body weight of at least 45.0 kg; body mass index (BMI) within the range of 19.0 to 26.0 kg/m², inclusive of boundary values. 4. All subjects, including males, agreed to abstain from reproductive plans from two weeks prior to screening until six months after the last administration of the investigational drug. Subjects committed to using effective contraceptive measures voluntarily and had no plans for sperm or egg donation. Furthermore, they guaranteed the use of one or more non-pharmacological contraceptive methods during sexual activity from two weeks prior to screening until one month after the last dose of the study drug. From one month after the final administration of the study drug to six months thereafter, subjects continued to use one or more contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Individuals with a known hypersensitivity to methylphenidate hydrochloride or any of its components; individuals with a documented history of allergic reactions to one or more medications, foods, or other substances. 2. Individuals with a history of chronic or severe diseases affecting the cardiovascular, hepatic, renal, respiratory, hematologic, lymphatic, endocrine, immunologic, psychiatric, neurological, or gastrointestinal systems. 3. Patients diagnosed with glaucoma. 4. Individuals with dysphagia (difficulty swallowing). 5. Individuals who frequently experience diarrhea or have bowel movements at least three times daily, individuals with a history of constipation or recent episodes of constipation. 6. Individuals with a history of orthostatic hypotension or syncope. 7. Individuals who have undergone surgery within three months before screening, those planning to undergo surgery during the study period, or those who have had surgical procedures that may affect drug absorption, distribution, metabolism, or excretion. 8. Individuals with difficult venous access, intolerance to venipuncture, or a history of vasovagal reactions related to needle insertion or blood draw. 9. Individuals with lactose intolerance (e.g., those experiencing diarrhea after consuming milk) or those with specific dietary restrictions that prevent adherence to a standardized diet. 10. Individuals with a history of substance abuse or dependence, or those who test positive for drugs of abuse during the trial (including morphine, ketamine, and methamphetamine). 11. Individuals who have participated in other clinical trials involving investigational drugs within three months before screening, or individuals who did not participate in clinical trials themselves but are currently enrolled in another trial. 12. Individuals who have donated blood or blood products totaling =400 mL within three months before screening, or who plan to donate during the study period; 13. Female subjects who are pregnant, lactating, or who have tested positive on a pregnancy test during the trial; 14. Individuals who have taken any medication known to inhibit or induce hepatic drug metabolism within four weeks before screening (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 15. Individuals who have used any prescription medications, over-the-counter drugs, herbal remedies, or dietary supplements within two weeks before screening; 16. Individuals who have received any vaccination within four weeks before screening, or who are scheduled to receive one during the study period; 17. Individuals who smoked more than five cigarettes per day within three months before screening, or who are unable to abstain from tobacco use throughout the study period; 18. Individuals who consumed more than 14 units of alcohol per week within three months before screening (1 unit ˜ 360 mL beer, 45 mL spirits at 40% alcohol content, or 150 mL wine), or who are unable to refrain from alcohol consumption during the trial period; or individuals with a positive breath alcohol test result; 19. Individuals who consumed excessive amounts of tea, coffee, or other caffeine-containing beverages (more than eight cups daily, 1 cup = 250 mL) within three months before screening; 20. Individuals who have consumed pitaya, mango, pomelo, s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, maximum plasma concentration;AUC0-t, area under the concentration-time curve from zero to the last measurable concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, time to peak concentration; | — |
Countries
China
Contacts
Public ContactShen Aizong
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed