HealthyPhase 1NCT06991634

A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects

A Phase 1 study testing Azvudine tablets in people with Healthy, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Azvudine tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 8 Apr 2023to 20 Jun 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult subjects :
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 ;
Healthy elderly subjects :
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 ) ) ;

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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.
Healthy adult subjects and healthy elderly subjects :
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 ;
Understand and sign the informed consent.

Who cannot join

Healthy adult subjects:
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;
Healthy elderly subjects:
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;

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Healthy adult subjects and healthy elderly subjects:
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;
Those who have participated in other clinical trials within 3 months before screening;
Drinking excessive amounts of tea, coffee and/or drinks rich in caffeine, xanthine and alcohol (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening;
Smoking history within 12 months before screening (smoking number ≥ 5 cigarettes per day);
Those with a history of alcohol abuse within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or those with a positive alcohol breath test (detection value> 0mg/100mL) before entering the group;
Those with a history of drug abuse within 12 months prior to screening or those who tested positive for addictive substances before entering the group;
Blood loss or blood donation ≥ 200mL within 8 weeks before screening (except for female physiological blood loss);
Pregnant and lactating women;
Those who cannot tolerate venipuncture blood collection and/or those who have a history of bleeding, acupuncture and/or blood collection vascular conditions are poor;
Those who have received the new coronavirus vaccine within 14 days before screening or other vaccines within 3 months before screening, or plan to receive the vaccine during the trial period;
The investigator considered it unsuitable to enter this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Fifth Central Hospital
Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: An Open, Parallel Design Clinical Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects in Single and Multiple Doses

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.

Conditions: Healthy
Being tested: Azvudine tablets
Keywords: Azvudine, Pharmacokinetics, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azvudine tabletsDrug
Phase I: oral administration of 5 mg of Azvudine tablets on an empty stomach, single dose, 5 mg per dose.
Phase II: oral administration of 5 mg of Azvudine tablets once a day on an empty stomach, 5 mg once a day, for 7 consecutive days.

Study groups in NCT06991634
Study group	Role	What they receive
Healthy adult subjects	Experimental	Not described Receives: Drug: Azvudine tablets
Healthy elderly subjects	Experimental	Not described Receives: Drug: Azvudine tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Azvudine
Measured: Up to 36 hours post-dose.
Pharmacokinetics (PK): Area Under the Plasma Concentration Curve (AUC) of Azvudine
Measured: Up to 36 hours post-dose.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration (Tmax) of Azvudine
Measured: Up to 36 hours post-dose.
Pharmacokinetics (PK): Elimination Half-life (T1/2) of Azvudine
Measured: Up to 36 hours post-dose.

Secondary outcomes (1)

Occurrence of Adverse Events
Measured: From enrollment to the end of the study on Day 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202320 Jun 2023

First posted28 May 2025
Study start8 Apr 2023
Primary completion27 Apr 2023
Study completion20 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06991634
Sponsor's protocol ID: CR-FNC-111
Status last verified: May 2025
First submitted: 8 May 2025
Last updated: 17 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Parallel Design Clinical Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects in Single and Multiple Doses
ClinicalTrials.gov ID: NCT06991634
Acronym / sponsor ID: CR-FNC-111
Conditions: Healthy
Keywords: Azvudine, Pharmacokinetics, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Apr 2023 (actual)
Primary completion: 27 Apr 2023 (actual)
Study completion: 20 Jun 2023 (actual)
First posted: 28 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy adult subjects	Experimental	Drug: Azvudine tablets
Healthy elderly subjects	Experimental	Drug: Azvudine tablets

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azvudine tabletsPhase I: oral administration of 5 mg of Azvudine tablets on an empty stomach, single dose, 5 mg per dose. Phase II: oral administration of 5 mg of Azvudine tablets once a day on an empty stomach, 5 mg once a day, for 7 consecutive days.	Drug	Healthy adult subjects, Healthy elderly subjects

Primary outcome

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Azvudine
Time frame: Up to 36 hours post-dose.
Pharmacokinetics (PK): Area Under the Plasma Concentration Curve (AUC) of Azvudine
Time frame: Up to 36 hours post-dose.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration (Tmax) of Azvudine
Time frame: Up to 36 hours post-dose.
Pharmacokinetics (PK): Elimination Half-life (T1/2) of Azvudine
Time frame: Up to 36 hours post-dose.

1 secondary outcome

Occurrence of Adverse Events
Time frame: From enrollment to the end of the study on Day 12.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azvudine tablets in people with Healthy, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Azvudine (time frame: Up to 36 hours post-dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06991634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.