Status:
COMPLETED
Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects
Lead Sponsor:
Vigonvita Life Sciences
Conditions:
Erectile Dysfunction
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.
Eligibility Criteria
Inclusion
- ≥ 65 years old；
- Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
- No major organ dysfunction；normal heart, liver and kidney function;
- Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent
Exclusion
- Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
- Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
- Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion;
- Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
- With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；
- A history of sudden decrease or loss of hearing；
- A history of postural hypotension；
- Blood loss ≥400 mL within 3 months before inclusion；
- Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
- Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ;
- A history of drug use or have been screened positive for drug abuse;
- Smoked more than 10 cigarettes a day within 6 months prior to inclusion;
- hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
- Other factors that the investigator considered inappropriate for the study.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06090136
Start Date
September 14 2020
End Date
July 22 2022
Last Update
October 19 2023
Active Locations (1)
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1
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China, 200031