A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects… (NCT06991634) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects
China24 participantsStarted 2023-04-08
Plain-language summary
Azvudine (FNC), a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase (RdRp). This is an open, parallel design clinical study to evaluate the pharmacokinetics and safety of Azvudine tablets in healthy adult and elderly subjects in single and multiple doses. The study is divided into two stages. In the first stage, after a single oral administration of 5 mg of Azvudine tablets, biological sample collection and safety examination were performed. After completing the first phase of the test, the subjects can enter the second phase of the test after a 3-day washout period, and received oral administration of 5 mg Azvudine tablets once a day for 7 consecutive days, biological samples were collected and safety tests were performed.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
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
. Age ≥ 18 years old and ≤ 45 years old, regardless of gender ;
. Body mass index ( BMI ) in the range of 19.0-26.0 ( including the critical value ) ( BMI = weight ( kg ) / height 2 ( m2 ) ), male weight should be ≥ 50.0kg, female weight should be ≥ 45.0kg ;
. Age ≥ 60 years old and ≤ 85 years old, regardless of gender ;
. Body mass index ( BMI ) in the range of 18.0-35.0 ( including the critical value ) ( BMI = weight ( kg ) / height 2 ( m2 ) ) ;
. Before the test, the existing disease if any was in a stable state and the treatment intervention or medication had no effect on this study.
. Patients who had no plan to become pregnant within 2 weeks before screening and 3 months after the end of the trial and agreed to take effective non-drug contraception during the trial ;
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.
What they're measuring
1
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Azvudine
Timeframe: Up to 36 hours post-dose.
2
Pharmacokinetics (PK): Area Under the Plasma Concentration Curve (AUC) of Azvudine
Timeframe: Up to 36 hours post-dose.
3
Pharmacokinetics (PK): Time to Maximum Plasma Concentration (Tmax) of Azvudine
Timeframe: Up to 36 hours post-dose.
4
Pharmacokinetics (PK): Elimination Half-life (T1/2) of Azvudine
. The medical history, physical examination, laboratory items before the test, and the test-related examinations and test abnormalities have clinical significance, and the clinical research doctor judges that they are not eligible;
. Subjects who have any history of prescription drugs, over-the-counter drugs, Chinese herbal medicines and healthcare products within 14 days before screening;
. History or evidence of cardiovascular disease prior to screening: uncontrolled hypertension (SBP ≥ 170 mmHg and/or DBP ≥ 105 mmHg without antihypertensive therapy; SBP\>160mmHg and/or DBP\>100 mmHg with antihypertensive therapy), orthostatic hypotension, severe arrhythmias, heart failure, Adams-Stokes syndrome, unstable angina, history of myocardial infarction within 6 months prior to screening, tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥ 450ms(Fridericia method);
. The mini-mental state examination (MMSE) score results judged by the investigator are not suitable for this study;
. Allergic constitution, history of drug or food allergy, especially allergic to any ingredient in this product and accessories;
. Patients with severe infection, trauma, or major surgery 4 weeks before screening, or who are scheduled to undergo surgery during the study;
. Fever within 3 days before screening;
. Those with serious diseases such as cerebral infarction and cancer in the past, except for benign diseases (such as liver cyst, renal cyst, fatty liver, etc.) based on chest radiograph and color Doppler ultrasound that do not need treatment;