Vertigo
Conditions
Interventions
TR:Phase I: Difenidol Hydrochloride Tablet manufactured by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.
Phase II: Difenidol Hydrochloride Tablet manufactured by NIPPON SHINYAKU Co.,Ltd.
RT:Phase I: Difenidol Hydrochloride Tablet manufactured by NIPPON SHINYAKU Co.,Ltd.
Phase II: Difenidol Hydrochloride Tablet manufactured by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years (including 18 years old), male or female; 2. Weight: Male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including the boundary value); 3. Sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study; 4. Volunteers can communicate well with researchers and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Chronic or active digestive tract diseases such as esophageal diseases, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years; 2. Those who have suffered from chronic or serious diseases such as eye, liver, kidney, digestive tract, endocrine system, cardiovascular and cerebrovascular system, nervous system, metabolic system, blood system, respiratory system, autoimmune system or existing diseases of the above system; 3. Past or current history of urinary tract obstructive diseases such as drug eruption, urticaria, glaucoma, gastrointestinal obstruction, prostatic hypertrophy; 4. Operators who had undergone surgery within six months before the trial that would affect drug absorption, distribution, metabolism and excretion judged by the researchers; or those who had undergone surgery within four weeks before the trial; or those who planned to undergo surgery during the study period; 5. Drug abusers or those who used soft drugs (e.g. cannabis) or hard drugs (e.g. cocaine, phenylcyclohexylpiperidine) three months before the trial or who had a history of drug dependence one year before the trial; 6. Those who have special dietary requirements and cannot follow a unified diet; those who have difficulty swallowing; or those who are lactose intolerant; 7. Anaphylactic constitution (e.g. allergic to two or more medicines, food and pollen) or allergic to Difenidol or any of its excipients; 8. Those who drank excessive (more than 8 cups a day, 1 cup = 250ml) tea, coffee and / or caffeine-containing beverages within three months before screening, or those who did not agree to stop drinking tea, coffee and/or caffeine-containing beverages during the trial period; 9. Ingested any caffeine-containing food / beverage (such as coffee, tea, chocolate, etc.) or any grapefruit-rich beverage / food within 48 hours before administration; 10. Those who ingested a large amount of grapefruit-rich beverage or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening or who did not agree to stop eating the above-mentioned food during the experiment; 11. Intolerance to venous indwelling needle blood collection or fainting; 12. Drinkers or alcoholics who drank more than 14 standard units a week within the first three months of screening (1 standard unit containing 14 g of alcohol, such as 360 mL beer or 45 mL of 40% alcohol or 150 mL of wine) or those who could not stop drinking or any alcoholic product during the experiment; 13. Smokers or those who smoked more than or equal to five cigarettes a day for the first three months of screening; or those who could not stop using tobacco products during the trial period; 14. Anyone who has used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days before the first administration; 15. The first dose after vaccination within 3 months; 16. Any drug that may affect drug metabolism was used within 28 days before the first administration; 17. Participated in other clinical trials within 3 months before the first administration; 18. Those who had a history of blood donation or massiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactXin Li
Outcome results
None listed