Status:
COMPLETED
Drug-Drug Interaction (DDI) Study for TPN171H
Lead Sponsor:
Vigonvita Life Sciences
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,an...
Eligibility Criteria
Inclusion
- Healthy male subjects between the ages of 18 and 40 years;
- Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
- Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance;
- Take reliable contraceptive measures during the trial and within three months after taking the drug;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Exclusion
- Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
- Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- A history of postural hypotension;
- Patients with blood loss ≥400 mL within 3 months before inclusion;
- Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration;
- Participated in other drug clinical trials and received trial drugs within 3 months before administration;
- Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
- Smoking more than 10 cigarettes per day ;
- Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Patients with clinically significant Chest x-ray (posterioranterior) abnormalities;
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06090123
Start Date
January 1 2020
End Date
September 2 2020
Last Update
October 19 2023
Active Locations (1)
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1
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China, 200031