Schizophrenia Clinical Trial
Official title:
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets (200 mg) in Chinese Healthy Subjects Under Single Dose, Randomized, Open, Two Formulation, Two Sequence, Two Cycle, Double Crossover, Fasting, and Postprandial Conditions
The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 31, 2024 |
Est. primary completion date | October 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 1. Chinese male or female subjects aged = 18 years old (including 18 years old); 2. Weight: Male = 50 kg, female = 45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values, BMI=weight (kg)/height 2 (m2)); 3. During the screening period, the vital signs, physical examination, laboratory examination, and electrocardiogram of the subjects were found to be normal or abnormal, and were determined by the researchers to be clinically insignificant; 4. All fertile subjects agree to take appropriate and effective physical contraception measures for themselves and their partners from the screening period (female subjects from 2 weeks before screening) to the end of the experiment, and to take effective physical contraception and/or medication contraception measures within 6 months after the end of the experiment, without any plans for sperm or egg donation; 5. The subjects fully understand the purpose, nature, and potential adverse reactions of the experiment, understand and follow the research process, voluntarily participate, and sign an informed consent form; 6. Those who are able to communicate well with researchers and understand and comply with the requirements of this study. Exclusion Criteria: - 1. Those with a past or existing history of the following diseases or chronic/severe illnesses, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for subjects with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect drug absorption, distribution, metabolism, and excretion; 2. Screening subjects who have undergone surgery within the first 3 months, or who plan to undergo surgery during the study period, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion; 3. There is a history of food and drug allergies that researchers have determined to be clinically significant; Or known allergies to sulfamethoxide or its excipients, or a history of other allergic diseases (asthma, urticaria, eczema dermatitis); 4. Previous or existing history of vascular edema or peripheral edema; 5. Screening for individuals with blurred vision, visual abnormalities, diplopia, or fundus lesions within the first 14 days; 6. Individuals with oral diseases such as oral ulcers during the screening period; 7. Previous or existing xerostomia patients; 8. People with positive results of any test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody (TP Ab); 9. Screening for individuals with a history of drug abuse or positive urine drug abuse screening within the previous 12 months; 10. Regular drinkers within the first 6 months of screening, i.e. those who consume an average of more than 14 units of alcohol per week (1 unit ˜ 285 mL of beer with an alcohol content of 3.5%, 25 mL of spirits with an alcohol content of 40%, or 85 mL of wine with an alcohol content of 12%), or those who cannot dispose of alcohol 48 hours before administration until the end of the study, or those who have tested positive for alcohol breath during the screening period; 11. Smoking an average of more than 5 cigarettes per day in the first 3 months of screening; Or those who cannot give up smoking 48 hours before administration until the end of the study; 12. Receive blood transfusion or use blood products within 3 months before screening; Those who have donated blood or experienced significant bleeding (greater than 400 mL, except for blood loss during normal physiological periods in females) within 3 months before the first administration, or plan to donate blood or blood components during the study period or within 1 week after the end of the study; 13. Screening subjects who have participated or are currently participating in other clinical trials within the first 3 months (drug clinical trials are defined as those who have used clinical research drugs); 14. Screening subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, and functional vitamins within the previous 14 days; Or those who have received vaccines within 2 weeks before screening or those who have vaccination plans during the trial period; 15. Those who have special dietary requirements, cannot accept a unified diet, and comply with corresponding regulations; Or those who consume beverages (coffee, tea) or food (animal liver) rich in xanthine during the experiment, or consume fruits or juice such as grapefruit, grapefruit, mango, etc. that may affect drug metabolism; 16. Individuals with rare genetic diseases such as lactose or galactose intolerance, primary lactase deficiency, or glucose galactose malabsorption; 17. Pregnant or lactating female subjects; Female reproductive age subjects who engage in sexual activity without effective contraceptive measures within 14 days prior to signing the informed consent form; 18. Those with difficulty swallowing; 19. Patients with poor vascular puncture conditions, inability to tolerate venous puncture, or those with needle and blood fainting; 20. Other subjects deemed unsuitable by the researchers to participate in the study. |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Hospital of Qingdao University Phase I Clinical Research Center | Qingdao | Shandong |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of Qingdao University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | Evaluation of Peak Plasma Concentration (Cmax) | 48 hours | |
Primary | Area under the plasma concentration versus time curve (AUC0-t) | Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t | 48 hours | |
Primary | Area under the plasma concentration versus time curve (AUC0-8) | Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time | 48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |