Essential hypertension
Conditions
Interventions
Single-dose administration period:For the 4 mg single-dose phase, affix the 4 mg TY-0201R pad, and for the 8 mg single-dose phase, affix the 8 mg TY-0201R pad for 24 hours.
Repeated-dose administration period:Affix a single TY-0201R 8 mg pad once daily (i.e. for 24 hours) for 7 days.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who meet all of the following criteria based on the results of screening tests at a medical institution conducted within 4 weeks prior to administration: 1() Subjects aged 18-35 years at the date of informed consent; (2) Subjects whose weight is larger than 50.0 kg and whose BMI is between 18.5 and 27.0; (3) Subjects who are judged to be in good health by the principal investigator or sub-investigator based on the screening tests; 2. Subjects who are judged to be eligible by the principal investigator or sub-investigator based on the clinical, medical and physical examinations on the day prior to affixing the study drug; 3. For female subjects, who may become pregnant, or their partners, who have agreed to use appropriate contraception methods after providing informed consent and until 3 months after the end of the study; 4. Subjects who have received adequate explanation and understand the purpose, content, and expected outcome of this trial before participating, and who voluntarily give written consent to participate in the trial; 5. Subjects who can comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects currently under treatment for any diseases; 2. Subjects who have allergy to drugs, skin allergy or with a history of such allergy; 3. Subjects with liver, kidney or other diseases, which could affect drug metabolism or excretion, or with a history of such diseases; 4. Subjects with a history of allergic diseases such as asthma and hay fever; 5. Subjects whose systolic blood pressure (sitting position) is less than 100 mmHg at screening, and subjects with orthostatic hypotension as suspected by the principal investigator or sub-investigator, or subjects whose pulse rate (sitting position) is less than 50 beats/min; 6. Subjects who have clinically significant abnormalities, malfunctions, or diseases as observed in the physical, clinical, ECG examinations, etc. during screening; 7. Subjects whose skin condition is not normal; 8. Subjects with body hair that prevents affixing the study drug; 9. Subjects who cannot abstain from alcohol or smoking from 7 days prior to affixing the study drug in the single-dose administration period to the end of the final observation/examination in the repeated-dose administration period; 10. Subjects who have donated or plan to donate 400 mL or more of whole blood within 12 weeks prior to administration of the single-dose study drug, subjects who have donated or plan to donate 200 mL or more of whole blood within 4 weeks prior to administration of the single-dose study drug, or subjects who have donated or plan to donate component blood within 2 weeks prior to administration of the single-dose study drug; 11. Subjects who have taken or plan to take any drug (including OTC drugs) within 2 weeks prior to administration of the single-dose study drug; 12. Subjects who have or plan to consume food or beverages containing grapefruit (juice, fruit), nutritional supplements or beverages containing St. John's wort within 7 days prior to administration of the study drug in the single-dose administration period; 13. Subjects who have consumed or intend to consume alcohol or alcohol-containing food or drinks within 7 days prior to affixing the study drug in the single-dose administration period; 14. Subjects who have performed or are planning to do strenuous exercise or heavy work involving sweating within 3 days prior to the administration of the single-dose study drug; 15. Subjects who have participated in other clinical trials within 2 weeks prior to administration of the single-dose study drug. This excludes subjects who have participated in other clinical trials but who have not received any study drugs; 16. Subjects who tested positive for any of the diagnostic screening tests (HIV, HBsAg, HCV-Ab, syphilis antibody test or urine drug test/smoking screening); 17. Subjects who are pregnant, lactating, possibly pregnant or intend to become pregnant during the study period; 18. Any other subjects who are judged by the principal investigator or sub-investigator to be an ineligible for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Safety; | — |
Countries
China
Contacts
Public ContactHaiyan Li
Peking University Third Hospital
Outcome results
None listed