Overactive bladder
Conditions
Interventions
Fed Group (T-R):Take the test preparation in the first cycle and the reference preparation in the second cycle
Fed Group (R-T) :Take the reference preparation in the first cycle and the test preparation in the second cycle
Fasting Froup(T-R):Take the test preparation in the first cycle and the reference preparation in the second cycle
Fasting Froup(R-T):Take the reference preparation in the first cycle and the test preparation in the second cycle
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged between 18 and 50 (inclusive), both male and female; 2. Male weight =50kg, female weight =45kg, and body mass index (BMI) between 19.0 and 26.0kg/m2 Interval (including boundary value); 3. Willing to sign an ICF; 4. Capable of maintaining good communication with the investigators and comply with the requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1.Alcohol and tobacco addicts (14 units of alcohol per week in the month before first dosing: 1 unit =10mL pure Alcohol, which is about 285 mL for 3.5 percent alcohol beer, 25 mL for 40 percent alcohol spirits, or 83mL for 12 percent wine; =5 cigarettes per day in the 3 months prior to first dose) and/ or those who cannot ban smoking and alcohol during the test period; 2. Use of any prescription drug within 4 weeks before the first dose, or use of any over-the-counter drug (vitamins, herbal supplements) within 2 weeks before the first dose, or use of any food that affects metabolism, such as grapefruit or drinks containing grapefruit, grapefruit, dragon fruit, mango and other fruits or related products within 2 weeks before the first dose; 3. Participants who have participated in any drug clinical trial as a subject within 3 months before the initial administration; 4. Those who received vaccines, including but not limited to COVID-19 vaccines, within three months prior to the first dose; 5. People who donate blood or blood loss = 200mL within 8 weeks prior to the first dose, or plan to donate blood during the trial period; 6. Previous history of food or drug allergy, or allergic constitution; A history of allergy to midanaxine or a clear history of allergy to any excipients in the investigational medicinal product; 7. Persons with genetic galactose intolerance, lactase deficiency or glucone-galactose malabsorption; 8. Any abnormal results of physical examination, vital signs, electrocardiogram, urine flow rate, intraocular pressure examination or clinical laboratory test during screening are clinically significant; 9. Any of the following should be satisfied in the resting state during screening: a) Systolic blood pressure 100bpm; d) Body temperature (ear temperature) 37.7?; 10. Diseases with abnormal clinical manifestations requiring exclusion, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and bone system, etc. Such as a history of inflammatory bowel disease, gastritis or rectal bleeding, pancreatic injury or pancreatitis, urinary tract infection, dysuria, urinary calculi, bladder cancer, prostate cancer, prostatic hypertrophy, arrhythmia, ocular pressure, thyroid dysfunction, Parkinson's disease, cerebrovascular disease, and a history of dementia or cognitive dysfunction; 11. Patients with glaucoma, urinary retention, gastric and duodenal ulcers, bladder neck obstruction, ulcerative colitis, pylorus, duodenal or intestinal obstruction, myasthenia gravis, and severe cardiac insufficiency; 12. Patients who have undergone major surgical operations within 3 months before the first dose; A history of severe vomiting, diarrhea, or any other disease or physical condition that interferes with the test results within the week prior to the initial administration; 13. Positive results of HIV, HBsAg, HCV antibody or TPPA; 14. A history of drug use, drug abuse or drug dependence; 15. Patients with a history of fainting needles and fainting blood, or who cannot tolerate venous puncture blood collection and have a known tendency to severe bleeding; 16. Pregnant or lactating women, or female subjects with positive pregnancy test results; The subject (or his or her partner) p
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Vital sign examination;12 lead electrocardiogram test;peak time;half life;clearance rate, CL; | — |
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Laboratory examination;Adverse event;peak concentration;Area under the plasma concentration-time curve from time 0 to the last selected time point;area under the plasma concentration time curve; | — |
Countries
China
Contacts
Public ContactDing Xueying
Shanghai General Hospital
Outcome results
None listed