HealthyPhase 1NCT07001501
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)
A Phase 1 study testing Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)
- 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
- 21 Feb 2022to 13 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects aged 18 years or older (including 18 years) with an appropriate ratio of male to female participants;
- The weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg. Body mass index (BMI) within the range of 19.0-26.0 (including the critical value).;
- All fertile male and female subjects agreed to take appropriate and effective physical contraceptive measures from the screening period until the end of the trial, and to use effective physical and/or pharmacological contraceptive measures for 6 months after the trial ends, with no plans for sperm or egg donation;
- Subjects fully understand the purpose, nature, process of the trial, and the potential adverse reactions, voluntarily agree to participate as subjects, and sign an informed consent form prior to the commencement of all study procedures;
- Subjects must be able to communicate effectively with the researchers and understand and comply with all requirements of this study.
Who cannot join
- Individuals with allergic constitutions, a history of drug or food allergies, especially those allergic to any components of this product and its excipients;
- Individuals with a previous history of hypoglycemia;
- Individuals who have abnormal results from physical examinations, vital signs check, clinical laboratory tests, 12-lead electrocardiograms, and other pre-trial relevant examinations, deemed clinically significant by the clinical researcher, and considered unqualified (normal reference range for vital signs: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <60 mmHg or >90 mmHg; pulse <60 bpm or >100 bpm);
- Individuals with a history of alcohol abuse within the 12 months prior to screening (consuming ≥14 units of alcohol weekly: 1 unit = 285 ml of beer, or 25 ml of spirits, or 150 ml of wine) or those with positive alcohol breath test results before enrollment (test value >0 mg/100 ml);
- Individuals with a history of drug abuse or use of illicit substances within the 12 months prior to screening, including repeated or excessive use of various anesthetics and psychoactive substances, addictive drugs [MDMA (Ecstasy), Methamphetamine (Ice), Ketamine, Morphine, THC (Marijuana)] or those with a positive result on the five-panel drug test before enrollment;
- Individuals who had undergone surgery within 3 months prior to screening, especially those who had surgeries affecting drug absorption, distribution, metabolism, or excretion, or who plan to undergo surgery during the study;
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- Individuals who had used any drug that interacts with the trial medication within 30 days prior to screening, such as methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine, ergotamine, methylergometrine), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, CYP3A4 medium or strong inducers such as levoacemesadol, halofantrine, astemizole, imidolastine, terfenadine, serindole, benzylprodil, lecadipine, ivabradidine, domperidone and other CYP3A4 medium or strong inducers or CYP3A4/P-glycoprotein/BCRP substrates and erythromycin, azithromycin, levoxacin, etc.;
- Individuals with a past medical history of cardiovascular, liver, kidney, pulmonary, gastrointestinal, neurological diseases, particularly any surgical conditions or diseases that might affect drug absorption, distribution, metabolism, and excretion, or conditions that could pose risks to trial participants;
- Individuals with a history of mental illness (e.g., anxiety, depression);
- Individuals with febrile illnesses within 3 days prior to screening;
- Individuals who had received a novel coronavirus vaccine within 14 days prior to screening or received any other vaccine within 3 months prior to screening, or planed to receive a vaccine during the study;
- Individuals who had participated in other clinical trials and received medication within 3 months prior to screening;
- Individuals who consumed excessive amounts of tea, coffee, and/or beverages rich in caffeine, theobromine, and alcohol (more than 8 cups, with 1 cup = 250 ml) within 3 months prior to screening;
- Individuals who had used any prescription medications, over-the-counter drugs, herbal medicines, dietary supplements, and functional vitamins within 14 days before the first dose;
- Individuals who smoked an average of more than 5 cigarettes daily within 3 months prior to the first dose;
- Individuals who had donated blood or experienced significant blood loss (greater than 400 ml, excluding normal physiological bleeding in women) within 3 months prior to the first dose, or who planed to donate blood or blood components during the study or within one week after the study;
- Females who tested positive for pregnancy; pregnant or breastfeeding women; female participants who engaged in unprotected sexual intercourse with a partner within 14 days prior to the trial;
- Individuals with poor conditions for vascular puncture, or who could not tolerate venous blood sampling, and/or had a history of vasovagal syncope;
- Individuals deemed unsuitable for this study by the investigator.
- Individuals deemed unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Phase I Clinical Trial Research Center of Dongguan Kanghua Hospital
Guangdong
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 Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 days. Biological sample collection and safety examination were performed.
- Conditions
- Healthy
- Being tested
- Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)
- 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 Itraconazole Capsules (ICZ)Drug
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow:
FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days.
Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)Drug
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow:
ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days.
Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)Drug
This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow:
FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : FNC+ICZ;FNC;ICZ | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
| Group 2 : ICZ;FNC+ICZ; FNC | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
| Group 3 : FNC; ICZ; FNC+ICZ | Experimental | Not described Receives: Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
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 and Itraconazole
Measured: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine and Itraconazole
Measured: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine and Itraconazole
Measured: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 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 59.
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 start21 Feb 2022
- Primary completion25 Apr 2022
- Study completion13 Mar 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
- NCT07001501
- Sponsor's protocol ID
- KHYQZX-022-2021
- Status last verified
- May 2025
- First submitted
- 23 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 Itraconazole Capsules (ICZ)
- ClinicalTrials.gov ID
- NCT07001501
- Acronym / sponsor ID
- KHYQZX-022-2021
- 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
- 21 Feb 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 13 Mar 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 Itraconazole Capsules (ICZ) in healthy subjects. This is a single-center, randomized, open-label, three-cycles, three-treatment crossover clinical trial. Subjects was administered orally for 10 consecutive days each cycle, and the washout period between each cycle was 14 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+ICZ;FNC;ICZ | Experimental | Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
| Group 2 : ICZ;FNC+ICZ; FNC | Experimental | Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
| Group 3 : FNC; ICZ; FNC+ICZ | Experimental | Drug: Azvudine tablets(FNC) and Itraconazole Capsules (ICZ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects aged 18 years or older (including 18 years) with an appropriate ratio of male to female participants;
- The weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg. Body mass index (BMI) within the range of 19.0-26.0 (including the critical value).;
- All fertile male and female subjects agreed to take appropriate and effective physical contraceptive measures from the screening period until the end of the trial, and to use effective physical and/or pharmacological contraceptive measures for 6 months after the trial ends, with no plans for sperm or egg donation;
- Subjects fully understand the purpose, nature, process of the trial, and the potential adverse reactions, voluntarily agree to participate as subjects, and sign an informed consent form prior to the commencement of all study procedures;
- Subjects must be able to communicate effectively with the researchers and understand and comply with all requirements of this study.
Key exclusion criteria (20 listed)
- Individuals with allergic constitutions, a history of drug or food allergies, especially those allergic to any components of this product and its excipients;
- Individuals with a previous history of hypoglycemia;
- Individuals who have abnormal results from physical examinations, vital signs check, clinical laboratory tests, 12-lead electrocardiograms, and other pre-trial relevant examinations, deemed clinically significant by the clinical researcher, and considered unqualified (normal reference range for vital signs: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <60 mmHg or >90 mmHg; pulse <60 bpm or >100 bpm);
- Individuals with a history of alcohol abuse within the 12 months prior to screening (consuming ≥14 units of alcohol weekly: 1 unit = 285 ml of beer, or 25 ml of spirits, or 150 ml of wine) or those with positive alcohol breath test results before enrollment (test value >0 mg/100 ml);
- Individuals with a history of drug abuse or use of illicit substances within the 12 months prior to screening, including repeated or excessive use of various anesthetics and psychoactive substances, addictive drugs [MDMA (Ecstasy), Methamphetamine (Ice), Ketamine, Morphine, THC (Marijuana)] or those with a positive result on the five-panel drug test before enrollment;
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 Itraconazole Capsules (ICZ)This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days. | Drug | Group 1 : FNC+ICZ;FNC;ICZ |
| Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days; FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days. | Drug | Group 2 : ICZ;FNC+ICZ; FNC |
| Azvudine tablets(FNC) and Itraconazole Capsules (ICZ)This study consisted of 3 cycles, each cycle was administered orally for 10 consecutive days, and the washout period between each cycle was 14 days. Subjects were administered the drug as follow: FNC: 3 mg (1 tablet) each time, 1 time a day, orally, for 10 consecutive days; ICZ: 200 mg (2 capsules) each time, 1 time a day, orally, for 10 consecutive days; FNC 3 mg (1 tablet)+ICZ 200 mg (2 capsules) (taken at the same time), 1 time a day, orally, for 10 consecutive days. | Drug | Group 3 : FNC; ICZ; FNC+ICZ |
Primary outcome
Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax, ss) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
Pharmacokinetics (PK): Elimination of Terminal Half-Life (t1/2) of Azvudine and Itraconazole
Time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 of the study.
1 secondary outcome
Occurrence of Adverse Events
Time frame: From enrollment to the end of the study on Day 59.
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.
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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 Itraconazole Capsules (ICZ) 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 5 inclusion and 20 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 and Itraconazole (time frame: Blood samples were collected on Day 8, 9, 10, 31, 32, 33, 54, 55 and 56 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.