Drug-Drug Interaction (DDI) Study for TPN171H (NCT06090123) | Clinical Trial Compass
CompletedPhase 1
Drug-Drug Interaction (DDI) Study for TPN171H
China24 participantsStarted 2020-01-01
Plain-language 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 ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects
Who can participate
Age range
18 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);