HealthyPhase 1NCT07002268
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)
A Phase 1 study testing Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) in people with Healthy, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.
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 Tenofovir Alafenol Fumarate Tablets (TAF)
- 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
- 14 Mar 2022to 31 Aug 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 (abnormal vital sign reference ranges: seated blood pressure: systolic <90 mmHg or >140 mmHg, diastolic <60 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm);
- Individuals who smoked ≥5 cigarettes daily prior to screening;
- 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;
Show all 18Show fewer
- Individuals required to be vaccinated against COVID-19 according to the specified schedule during the study;
- 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 methadone, propafenone, domperidone, dronedarone, quinidine, ergot alkaloids (e.g., dihydroergotamine, ergometrine, ergotamine, methylergometrine), irinotecan, lurasidone, oral midazolam, pizotifen, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, dexmedetomidine, halofantrine, asimadoline, mizolastine, terfenadine, indoramine, benperidol, lacidipine, ivabradine, domperidone, and other moderate or strong CYP3A4 inducers or CYP3A4/P-glycoprotein/BCRP substrates and erythromycin, azithromycin, levofloxacin, etc.; whether a participant's use of medication within 30 days is determined by the investigator regarding its interaction with the trial drug;
- 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 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.
About this study
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 a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 7 consecutive days each cycle, and the washout period between each cycle was 10 days. Biological sample collection and safety examination were performed.
- Conditions
- Healthy
- Being tested
- Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)
- 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 Tenofovir Alafenol Fumarate Tablets (TAF)Drug
This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow:
FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days; TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days.
Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)Drug
This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow:
FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days; TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days.
Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)Drug
This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow:
TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: FNC+TAF;TAF;FNC | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
| Group 2: FNC;FNC+TAF;TAF | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
| Group 3: TAF;FNC;FNC+TAF | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
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, Tenofovir Alafenol and Tenofovir
Measured: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine, Tenofovir Alafenol and Tenofovir
Measured: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine, Tenofovir Alafenol and Tenofovir
Measured: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 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 40.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start14 Mar 2022
- Primary completion4 May 2022
- Study completion31 Aug 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)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002268
- Sponsor's protocol ID
- GQ-FNC-110
- Status last verified
- Apr 2025
- First submitted
- 13 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 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 Tenofovir Alafenol Fumarate Tablets (TAF)
- ClinicalTrials.gov ID
- NCT07002268
- Acronym / sponsor ID
- GQ-FNC-110
- 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
- 14 Mar 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 31 Aug 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.
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 a clinical study to evaluate the Interactions between Azvudine Tablets (FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 7 consecutive days each cycle, and the washout period between each cycle was 10 days. Biological sample collection and safety examination were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: FNC+TAF;TAF;FNC | Experimental | Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
| Group 2: FNC;FNC+TAF;TAF | Experimental | Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
| Group 3: TAF;FNC;FNC+TAF | Experimental | Drug: Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF) |
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 (abnormal vital sign reference ranges: seated blood pressure: systolic <90 mmHg or >140 mmHg, diastolic <60 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm);
- Individuals who smoked ≥5 cigarettes daily prior to screening;
- 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 Tenofovir Alafenol Fumarate Tablets (TAF)This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days; TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days. | Drug | Group 1: FNC+TAF;TAF;FNC |
| Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days; TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days. | Drug | Group 2: FNC;FNC+TAF;TAF |
| Azvudine tablets(FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)This study consisted of 3 cycles, each cycle was administered orally for 7 consecutive days, and the washout period between each cycle was 10 days. Subjects were administered the drug as follow: TAF: 25 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 7 consecutive days; FNC 3 mg (1 tablet)+TAF 25 mg (1 tablet) (taken at the same time), 1 time a day, orally, for 7 consecutive days. | Drug | Group 3: TAF;FNC;FNC+TAF |
Primary outcome
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine, Tenofovir Alafenol and Tenofovir
Time frame: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine, Tenofovir Alafenol and Tenofovir
Time frame: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine, Tenofovir Alafenol and Tenofovir
Time frame: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 of the study.
1 secondary outcome
Occurrence of Adverse Events
Time frame: From enrollment to the end of the study on Day 40.
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 3 Jun 2025.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Tenofovir Alafenol Fumarate Tablets (TAF) 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 3 Jun 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, Tenofovir Alafenol and Tenofovir (time frame: Blood samples were collected on Day 5, 6, 7, 22, 23, 24, 37, 38 and 39 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?
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 3 Jun 2025.