Depression
Conditions
Interventions
TR Sequence Group in the Fed Study:In the first cycle, take the test formulation T (1 tablet) after meals
in the second cycle, take the reference formulation R (1 tablet) on an empty stomach or after meals
washout period of 7 days.
RT Sequence Group in the Fasting Study:In the first cycle, take the reference formulation R (1 tablet) on an empty stomach
in the second cycle, take the test formulation T (1 tablet) on an empty stomach or after a meal
7-day washout period
TR Sequence Group in the Fasting Study:In the first cycle, take the test formulation T (1 tablet) after meals
RT Sequence Group in the Fed Study:In the first cycle, take the reference formulation R (1 tablet) after meals
in the second cycle, take the test formulation T (1 tablet) on an empty stomach or after meals
Sponsors
The Second Affiliated Hospital Of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects must fully understand the study objectives, nature, procedures, and potential adverse reactions, voluntarily agree to participate as study subjects, and sign the informed consent form approved by the Ethics Committee. 2.Healthy male or female subjects aged 18 years or older. 3.Healthy male or female subjects with a body weight of >=50.0 kg (male) or >=45.0 kg (female) and a body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive). 4.Subjects must be able to communicate effectively with the investigator and understand and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1.Subjects with abnormal vital signs, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function), physical examination, or 12-lead ECG that are judged by the investigator to be clinically significant. 2.Subjects with any abnormality in serology virology test results that are judged by the investigator to be clinically significant. 3.Subjects with any chronic or severe diseases or a history of diseases (e.g., epilepsy, hepatic or renal impairment, cardiac disease, hyperthyroidism, urinary retention, acute narrow-angle glaucoma, etc.) in the endocrine, urinary, digestive, hematologic and lymphatic, respiratory, cardiovascular, nervous, psychiatric, or musculoskeletal systems, as well as a history of relevant treatments (e.g., electroconvulsive therapy), which are judged by the investigator to be clinically significant. 4.Subjects who have undergone surgery, biopsy, or experienced severe trauma within the 6 months prior to screening, or who plan to undergo surgery during the trial, as well as those with any surgical history judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion. 5.Subjects with a history of orthostatic hypotension, currently experiencing orthostatic hypotension, or those found to have orthostatic hypotension during screening (measurement method as per Appendix 1). 6.Subjects who have used any prescription drugs, over-the-counter medications, or health supplements within 2 weeks prior to screening. 7.Subjects who have used drugs that may potentially interact with the investigational drug within 1 month prior to screening, including but not limited to: erythromycin, ketoconazole, itraconazole, saquinavir, ritonavir, indinavir, nefazodone, carbamazepine, barbiturates, cimetidine, fluoxetine, chlorpromazine, fluphenazine, levomepromazine, perphenazine, levodopa, clonidine, warfarin, digoxin, phenytoin, preparations containing St. John's wort (Hypericum perforatum), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), narcotics/muscle relaxants, and drugs that prolong the QT interval. 8.Subjects who have received any vaccination within 1 month prior to screening, or who plan to receive a vaccination during the study period. 9.Subjects with a history of drug abuse within the past year, those who have used illicit drugs, or those with a positive urine drug screen. 10.Subjects with a history of food or drug allergy (e.g., asthma, urticaria, eczema, anaphylactic shock, etc.), or allergic constitution, or those allergic to any component of the study drug (e.g., trazodone, sucrose, povidone, carnauba wax, magnesium stearate, etc.). 11.Subjects who have donated blood or experienced significant blood loss (>=400 mL), or received blood transfusions or blood products within 3 months prior to screening. 12.Subjects who have engaged in unprotected sexual activity within 2 weeks prior to screening; or who plan to become pregnant, donate sperm, or donate eggs during the entire study period and for 6 months after the trial, or are unwilling to use effective contraception. 13.Female subjects who are pregnant or breastfeeding; or who have used oral contraceptives within 1 month prior to screening; or who have used long-acting estrogen/progesterone injections, implants, or active contraceptive devices within 6 months prior to screening; or whose pregnancy test results are abnormal and judged to be clinically significant. 14.Subjects who have consumed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Fasting Test);Concentration-Time Curve from 0 to the Last Measurable Concentration (Fasting Test);Area Under the Plasma Concentration-Time Curve from 0 to Infinity (Fasting Test);Maximum Plasma Concentration (Postprandial Test);Concentration-Time Curve from 0 to the Last Measurable Concentration (Postprandial Test);Area Under the Plasma Concentration-Time Curve from 0 to Infinity (Postprandial Test); | — |
Countries
China
Contacts
Public ContactFengxue Guo
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed