For depression with or without anxiety symptoms
Conditions
Interventions
Fasting T-R Group:After an overnight fast, subjects received a single oral dose of 1 tablet (150 mg) of the test formulation (T), swallowed whole with approximately 240 mL of warm water. Seven days la
Fasting R-T Group:After an overnight fast, subjects received a single oral dose of 1 tablet (150 mg) of the reference formulation (R, TRITTICO?), swallowed whole with approximately 240 mL of warm wate
Fed T-R Group:After a high-fat meal, within 30 ± 0.5 minutes from the start of the meal, subjects received a single oral dose of 1 tablet (150 mg) of the test formulation (T), swallowed whole with app
Fed R-T Group:After a high-fat meal, within 30 ± 0.5 minutes from the start of the meal, subjects received a single oral dose of 1 tablet (150 mg) of the reference formulation (R, TRITTICO?), swallowe
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understood the research purpose, nature, methods and possible adverse reactions, voluntarily became subjects, and signed the informed consent form by themselves before the start of any research procedure; 2. Healthy male or female subjects aged >=18 years old; 3. Male weight >=50kg, female weight >=45kg; Body mass Index (BMI) within the range of 19.0 to 26.0kg/m ² (including the critical value); 4. Vital sign measurement, physical examination, clinical laboratory tests (blood routine test, urine dry chemistry + quantitative urine sediment test, blood biochemical test, eight-item infection test, four-item coagulation test, etc.), 12-lead electrocardiogram test, etc., those whose results show normal or abnormal but have no clinical significance; 5. All fertile subjects had no fertility plans from the signing of the informed consent form to within 6 months after the end of the trial, voluntarily took appropriate and effective contraceptive measures (including the partners of male subjects), and had no plans for sperm or egg donation; 6. Those who can communicate well with researchers and understand and comply with all the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Allergic constitution, such as those with a known history of allergy to two or more substances, or those with a known history of previous allergy to trazodone hydrochloride and related excipients; 2.Those who developed acute diseases during the screening stage before the study or before the study of medication; 3.Those who have had or are currently suffering from the following diseases or have a history of chronic/serious diseases and whose study doctors consider it still of clinical significance at present Including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system (hyperthyroidism), immune system, mental and nervous system (epilepsy), skeletal system, ophthalmic diseases (acute narrow-angle glaucoma), etc. Especially for those suffering from gastrointestinal dysfunction, peptic ulcers and other gastrointestinal diseases that affect drug absorption, distribution, metabolism and excretion; 4.Those with any history of (acute or chronic) mental illness or a family history of mental illness; 5.Those with a previous history of QT prolongation and/or torsional ventricular tachycardia at the tip (including a history of congenital long QT syndrome); 6.Those who have experienced diseases or surgeries that were judged by the researchers to affect drug absorption, distribution, metabolism or excretion within 3 months before the screening, or those who plan to undergo surgery during the study period and within 1 week after the end of the study; 7.Those who have used any medication (including prescription drugs, over-the-counter drugs, Chinese herbal medicines), health supplements or functional vitamins within two weeks prior to the first administration; 8.Those who have previously taken or are currently taking drugs for treating neurological and mental disorders such as antipsychotic, antidepressant, and anti-anxiety diseases; 9.Any drugs that interact with trazodone (erythromycin, antifungal drugs (ketoconazole) have been used within 28 days before the first administration. Itraconazole, HIV protease inhibitors (ritonavir, indenavir), nefazolidone, phenytoin, carbamazepine and barbiturates, cimetidine and some other antipsychotic drugs, carbamazepine, tricyclic antidepressants, fluoxetine, monoamine oxidase inhibitors, phenothiazine drugs, anesthetics/muscle relaxants, levodopa, clonidine, and transvestite The drugs of Forsythia suspensa include warfarin and digoxin; 10.Those who have received vaccination within 4 weeks before screening, or plan to receive any vaccine during the trial or within 1 week after the end of the study; 11.Those who have participated in other drug clinical trials within 3 months prior to the screening (participating in drug clinical trials is defined as having used the drugs used in clinical research); 12.Those who smoked more than 5 cigarettes per day on average within 3 months before screening, or were unable to stop using any tobacco products (including any smoking cessation products containing nicotine) during the trial period; 13.Those who consumed more than 14 units of alcohol per week on average within one year before screening (1 unit =360mL of beer or 45mL of 40% alcohol liquor or 150 ml of wine), or were unable to abdication from alcohol during the test period, or had an alcohol breath test result greater than 0.0mg/100mL; 14.Those with orthostatic hypotension; 15.Those who have a history of drug abuse (including repeated and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vd/F;t1/2;t1/2;CL/F;AUC_%Extrap;Tmax;?z;F;Tmax; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed