HealthyPhase 1NCT07002242

A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia

A Phase 1 study testing Azvudine tablets(FNC) and Aluvia, Azvudine tablets(FNC) and Aluvia 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

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). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Azvudine tablets(FNC) and Aluvia, Azvudine tablets(FNC) and Aluvia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 6 Jul 2022to 21 Feb 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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects aged ≥ 18 years old and ≤ 45 years old, regardless of gender;
Body mass index (BMI) within the range of 19.0-26.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
Those who had no birth plan within 2 weeks before screening and within 6 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial;
Understand and sign the informed consent form.

Who cannot join

Persons with allergic constitutions, history of drug or food allergies, especially those who were allergic to any ingredient in this product and its excipients;
Individuals with a history of hypoglycemia;
Individuals deemed ineligible by the clinical research physician due to significant clinical abnormalities in medical history, physical examination, laboratory tests, and other related examinations;
Individuals with a history of smoking addiction within 12 months prior to screening (the number of cigarettes smoked ≥5 per day);
Individuals with a history of alcohol abuse within the past 12 months (consuming ≥14 units of alcohol weekly: 1 unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine), or who tested positive for alcohol on breath tests prior to study enrollment (testing value >0mg/100mL);
Individuals with a history of substance abuse within the past 12 months or who tested positive for addictive substances prior to enrollment;

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Individuals who underwent surgery within the past 3 months, especially those who had had surgeries that would affect drug absorption, distribution, metabolism, or excretion, or those planning to undergo surgery during the study;
Individuals who had taken any medication that interacts with the trial drug in the 30 days prior to screening, such as strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, etc.);
Individuals with a history of cardiovascular, liver, kidney, pulmonary, gastrointestinal, neurological diseases, especially any surgical conditions or disorders that might affect drug absorption, distribution, metabolism, and excretion, or any surgical conditions or disorders that might pose hazards to participants;
Individuals with febrile illness within the 3 days prior to screening;
Individuals who had participated in any other clinical trials within the past 3 months;
Individuals with any history of prescription drugs, over-the-counter drugs, herbal medicine, or dietary supplements within 14 days prior to screening;
Individuals who had been vaccinated against the novel coronavirus within 14 days before screening or other vaccines within 3 months before screening or planed to be vaccinated during the trial;
Individuals who had consumed excessive tea, coffee, and/or caffeinated, xanthine, or alcoholic beverages (more than 8 cups, 1 cup = 250 mL) daily within the 3 months prior to screening;
Individuals who had lost blood or donated ≥200 mL within the past 8 weeks;
Pregnant or breastfeeding women;
Individuals who could not tolerate venipuncture or had a history of vasovagal syncope;
Individuals deemed unsuitable for this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin People's Hospital
Tianjin

Other trials in China

About this study

This is a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Aluvia in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 5 consecutive days each cycle, and the washout period between each cycle was 7 days. Biological sample collection and safety examination were performed.

Conditions: Healthy
Being tested: Azvudine tablets(FNC) and Aluvia, Azvudine tablets(FNC), Aluvia
Keywords: Azvudine

What participants receive

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

Azvudine tablets(FNC) and AluviaDrug
FNC 3 mg each time, 1 time a day, orally, for 5 consecutive days. Aluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.
Azvudine tablets(FNC)Drug
FNC: 3 mg each time, 1 time a day, orally, for 5 consecutive days
AluviaDrug
Aluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.

Study groups in NCT07002242
Study group	Role	What they receive
Group 1 : FNC+ Aluvia;Aluvia;FNC	Experimental	Not described Receives: Drug: Azvudine tablets(FNC) and Aluvia; Drug: Azvudine tablets(FNC); Drug: Aluvia
Group 2 : FNC;FNC+Aluvia;Aluvia	Experimental	Not described Receives: Drug: Azvudine tablets(FNC) and Aluvia; Drug: Azvudine tablets(FNC); Drug: Aluvia
Group 3 : Aluvia;FNC;FNC+Aluvia	Experimental	Not described Receives: Drug: Azvudine tablets(FNC) and Aluvia; Drug: Azvudine tablets(FNC); Drug: Aluvia

What is being measured

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

Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine, Lopinavir and Ritonavir
Measured: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine, Lopinavir and Ritonavir
Measured: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine, Lopinavir and Ritonavir
Measured: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.

Secondary outcomes (1)

Occurrence of Adverse Events
Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.
Measured: From enrollment to the end of the study on Day 28.

Timeline

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

6 Jul 202221 Feb 2023

First posted3 Jun 2025
Study start6 Jul 2022
Primary completion25 Aug 2022
Study completion21 Feb 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07002242
Sponsor's protocol ID: GQ-FNC-108
Status last verified: Sep 2025
First submitted: 13 May 2025
Last updated: 2 Oct 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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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia
ClinicalTrials.gov ID: NCT07002242
Acronym / sponsor ID: GQ-FNC-108
Conditions: Healthy
Keywords: Azvudine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Jul 2022 (actual)
Primary completion: 25 Aug 2022 (actual)
Study completion: 21 Feb 2023 (actual)
First posted: 3 Jun 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1 : FNC+ Aluvia;Aluvia;FNC	Experimental	Drug: Azvudine tablets(FNC) and Aluvia, Drug: Azvudine tablets(FNC), Drug: Aluvia
Group 2 : FNC;FNC+Aluvia;Aluvia	Experimental	Drug: Azvudine tablets(FNC) and Aluvia, Drug: Azvudine tablets(FNC), Drug: Aluvia
Group 3 : Aluvia;FNC;FNC+Aluvia	Experimental	Drug: Azvudine tablets(FNC) and Aluvia, Drug: Azvudine tablets(FNC), Drug: Aluvia

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy subjects aged ≥ 18 years old and ≤ 45 years old, regardless of gender;
Body mass index (BMI) within the range of 19.0-26.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
Those who had no birth plan within 2 weeks before screening and within 6 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial;
Understand and sign the informed consent form.

Key exclusion criteria (18 listed)

Persons with allergic constitutions, history of drug or food allergies, especially those who were allergic to any ingredient in this product and its excipients;
Individuals with a history of hypoglycemia;
Individuals deemed ineligible by the clinical research physician due to significant clinical abnormalities in medical history, physical examination, laboratory tests, and other related examinations;
Individuals with a history of smoking addiction within 12 months prior to screening (the number of cigarettes smoked ≥5 per day);
Individuals with a history of alcohol abuse within the past 12 months (consuming ≥14 units of alcohol weekly: 1 unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine), or who tested positive for alcohol on breath tests prior to study enrollment (testing value >0mg/100mL);

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 tablets(FNC) and AluviaFNC 3 mg each time, 1 time a day, orally, for 5 consecutive days. Aluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.	Drug	Group 1 : FNC+ Aluvia;Aluvia;FNC, Group 2 : FNC;FNC+Aluvia;Aluvia, Group 3 : Aluvia;FNC;FNC+Aluvia
Azvudine tablets(FNC)FNC: 3 mg each time, 1 time a day, orally, for 5 consecutive days	Drug	Group 1 : FNC+ Aluvia;Aluvia;FNC, Group 2 : FNC;FNC+Aluvia;Aluvia, Group 3 : Aluvia;FNC;FNC+Aluvia
AluviaAluvia(Lopinavir / Ritonavir tablets): 400 mg/100 mg (2 tablets) each time, 2 time a day, orally, for 5 consecutive days.	Drug	Group 1 : FNC+ Aluvia;Aluvia;FNC, Group 2 : FNC;FNC+Aluvia;Aluvia, Group 3 : Aluvia;FNC;FNC+Aluvia

Primary outcome

Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine, Lopinavir and Ritonavir
Time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.

1 secondary outcome

Occurrence of Adverse Events
Time frame: From enrollment to the end of the study on Day 28.

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 2 Oct 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(FNC) and Aluvia, Azvudine tablets(FNC) and Aluvia 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 4 inclusion and 18 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 2 Oct 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 at Steady State (Cmax, ss) of Azvudine, Lopinavir and Ritonavir (time frame: Blood samples were collected on Day 3, 4, 5, 14, 15, 16, 25, 26 and 27 of the study.). The study lists 3 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 NCT07002242.

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 2 Oct 2025.