Overactive Bladder
Conditions
Interventions
Cohort 1:One 50mg tablet
Cohort 2:Two 50mg tablets
Cohort 3:one 75 mg table during single dose period, 75mg tablet QD for 8 days during the multiple dose period
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese men or women aged 18-45 (including the threshold) at the time of screening; 2. Body mass index is 19.0-26.0 kg / m2 (including critical value), male body weight is not less than 50.0 kg, female body weight is not less than 45.0 kg; 3. Subjects without obvious physical abnormality through comprehensive clinical evaluation (detailed medical history and complete physical examination); 4. Subjects whose blood pressure and pulse measured in half lying position after 5 minutes rest are in the following range: – SBP 90 to 140 mmHg – DBP 60 to 90 mmHg – pulse 60 to 100 BPM 5. The laboratory test results shall be within the normal value range or the researchers think that the abnormal results have no clinical significance for healthy subjects. However, serum creatinine (CR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBIL) should not exceed 1.2 times of the upper limit of the normal value; 6. Subjects with normal or abnormal 12 lead electrocardiogram (ECG), QRS < 120 ms and QTc < 450 ms; 7. Subjects who had no pregnancy plan and voluntarily took effective contraceptive measures from the trial period to 3 months after the last study administration, and had no sperm donation or egg donation plan; 8. Subjects who can understand the process and method of the study, sign the written informed consent voluntarily and can complete the test according to the test scheme.
Exclusion criteria
Exclusion criteria: 1. Patients with any systemic disease symptoms or chronic or serious disease history, including but not limited to cardiovascular, liver, kidney, gastrointestinal, respiratory, nerve, blood, immune, metabolic and other systemic diseases and tumors or other factors that may affect drug absorption, distribution, metabolism and excretion judged by researchers; 2. Patients who have a history of food or drug hypersensitivity, or a history of allergic diseases, or who are prone to rash, urticaria and other allergic symptoms; 3. Patients who have a history of orthostatic hypotension or who have had orthostatic hypotension during screening; 4. The patients with drug abuse history or positive drug abuse screening in screening period within 3 months before screening; 5. Smokers (the average number of cigarettes per day in the past 3 months is 5 or more or the same amount of cigarettes), and the objects who habitually use nicotine containing products; 6. In the six months before the screening, the weekly alcohol consumption was more than 14 units of alcohol (1 unit of alcohol = 360 ml of beer or 25 ml of spirits or 150 ml of wine with 40% alcohol content) or the alcohol containing products were taken 48 hours before the administration, or the subjects with positive alcohol breath test were screened and / or the baseline; 7. Study the subjects who have been vaccinated (such as influenza vaccine, varicella vaccine, etc.) or other biological agents within 28 days before the first administration; 8. Subjects who used any prescription drug, over-the-counter drug or Chinese herbal medicine within 14 days before the first administration of the study; 9. Subjects who had eaten grapefruit or drink containing grapefruit within 7 days before the first administration of the study, or who were unwilling to ban the above food or drink during the study period; 10. Those who have consumed excessive tea, coffee or caffeinated beverage for a long time (more than 8 cups a day, 1 cup = 250ml), or taken any food or beverage containing or metabolizing caffeine or xanthine (such as coffee, strong tea, cola, chocolate) within 48 hours before the first administration of the study, or who are unwilling to prohibit the above food or beverage during the study; 11. Subjects who participated in clinical trials of any drug or medical device within 3 months before the first administration of the study; 12. Blood donation within 3 months before screening, blood loss of more than 400 ml (except female physiological blood loss), or blood (component) transfusion, or plasma donation or plasma exchange within 7 days before screening; 13. Patients with HIV AB, TP AB, HBsAg or HCV AB positive; 14. Subjects who are expected to have surgical tendency during the trial; 15. Pregnant or lactating women, or screening or baseline pregnancy test positive objects; 16. Any other researcher believes that there are factors that are not suitable for participating in the test, such as the situation that may affect the provision of informed consent or the compliance with the test plan, or other situations that may affect the test results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Single-dose administration (50/75/100mg): Cmax, tmax, AUClast, AUCinf, AUC24h, t1/2z;Multiple-dose administration (75mg): Cmax, ss, tmax, ss, Cavg, ss, Cmin, ss, AUCtau, Rac (AUC) ac(Cmax), DF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse events (TEAE) as well as serious adverse events (SAE), laboratory examinations, physical examination, vital signs, and 12-ECG;Pharmacodynamics: The change in 24-h volume voided and average micturition frequency after 75 mg multiple doses; | — |
Contacts
Public ContactQing He
Wuxi People's Hospital
Outcome results
None listed