Chronic Hepatitis B Liver FibrosisPhase 1NCT07295873

Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide

A Phase 1 study testing Entecavir, Tenofovir Disoproxil Fumarate（TDF） and Tenofovir alafenamide（TAF） in people with Chronic Hepatitis B Liver Fibrosis and DDI (Drug-Drug Interaction), run by Beijing Continent Pharmaceutical 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 50 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Hepatitis B Liver Fibrosis, DDI (Drug-Drug Interaction)
What is being tested?: Entecavir, Tenofovir Disoproxil Fumarate（TDF） and Tenofovir alafenamide（TAF）
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteChina
Study dates: 15 Mar 2026to 29 May 2026
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Be fully informed about the trial and demonstrate understanding of its content, procedures, and potential adverse events related to the investigational product; voluntarily provide written informed consent; and be able to comply with all study procedures and complete the study in accordance with the protocol requirements.
Male or female subjects aged 18 to 50 years, inclusive, at the time of signing informed consent.
At screening, male subjects must weigh ≥50.0 kg and female subjects must weigh ≥45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive.
At screening, all laboratory tests and related examinations (including vital signs, physical examination, 12-lead ECG, chest X-ray [PA view], abdominal ultrasound, etc.) must be within normal range or, if abnormal, determined by the investigator to be not clinically significant.

Who cannot join

Presence of any clinically significant disease or medical history that, in the opinion of the investigator, may interfere with protocol compliance or completion of the study, including but not limited to abnormalities of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric system, or endocrine/metabolic system.
Positive results for any infectious disease screening tests at screening, including hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or Treponema pallidum antibody (TP Ab).
History of drug or food allergies, or known hypersensitivity to the active pharmaceutical ingredients of the investigational medicinal products (hydronidone, entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide) or to any of their excipients.
Participants with rare genetic disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Subjects who have experienced a clinically significant major illness within 3 months prior to screening, or have undergone surgery affecting drug absorption, distribution, metabolism, or excretion (such as gastrointestinal, hepatic, or renal surgery) or other major surgery within this period, or plan to undergo surgery during the study;
Subjects who have donated blood or experienced blood loss ≥400 mL within 3 months prior to dosing, or received blood transfusion or blood products within 4 weeks prior to dosing, or plan to donate blood during the study period;

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Subjects who have participated as a participant in any clinical trial and received investigational drug or device treatment within 3 months prior to dosing;
Subjects who have taken any prescription medication, over-the-counter medication, vitamin products, or herbal medicines within 14 days or 5 half-lives (if known) prior to dosing, whichever is longer; or who have taken strong inhibitors or inducers of CYP3A4, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3 within 4 weeks prior to screening; or any drugs known to cause QT/QTc interval prolongation or with a known risk of causing torsades de pointes (TdP) (see Appendix 2); or plan to use any chemical drugs, biological products, traditional Chinese medicines, or natural medicines that the investigator deems inappropriate during the trial period;
Subjects who received vaccination within 4 weeks prior to screening, or plan to receive vaccination during the study period up to 1 month after the last dose; Subjects with a history of drug abuse within the past 5 years, or who used illicit drugs within 3 months prior to screening, or with a positive urine drug abuse screen at baseline;
Subjects who regularly consumed alcohol within 6 months prior to dosing, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or who refuse to abstain from alcohol or alcohol-containing products during the trial, or with a positive alcohol breath test at baseline;
Subjects who smoked more than 5 cigarettes daily within 3 months prior to dosing, or who are unable to discontinue use of tobacco products during the trial period;
Subjects with a history of blood-needle phobia/syncope, or unable to tolerate venous indwelling needle puncture;
Subjects with special dietary requirements who cannot follow the standardized diet, or with difficulty swallowing;
Subjects unable to avoid specific foods/diet during the trial period, including dragon fruit, mango, grapefruit or grapefruit-related citrus fruits (e.g., Seville orange, pomelo), star fruit, papaya, pomegranate or products thereof, and/or xanthine-containing diet, caffeine-containing food or beverages, strong tea, etc.;
Subjects who consumed grapefruit or grapefruit-related citrus fruits (e.g., Seville orange, pomelo) or products thereof within 2 weeks prior to dosing, or who consumed specific diet (including dragon fruit, mango and/or xanthine-containing diet, caffeine-containing food or beverages, strong tea, etc.) within 48 hours prior to dosing, or engaged in strenuous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion;
Pregnant or lactating women, or female subjects of childbearing potential with a positive serum pregnancy test at screening;
Subjects of childbearing potential who do not agree to use effective contraceptive methods from the time of signing informed consent until 3 months after study completion (see Appendix 3), or do not agree to avoid freezing or donating eggs or sperm during this period;
Subjects who, in the opinion of the investigator, have other reasons that render them unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Gaobo Hospital
Beijing, 100000

Other trials in China

About this study

Official title: A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects

The proposed indication for Hydronidone Capsules is chronic hepatitis B-associated liver fibrosis, which in clinical practice typically requires concomitant use with antiviral agents for chronic hepatitis B. The commonly used chronic hepatitis B antiviral agents include Entecavir, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF), and Tenofovir Amibufenamide (TMF).

This study aims to evaluate the drug-drug interaction (DDI) of Hydronidone Capsules 90 mg with Entecavir, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF), and Tenofovir Amibufenamide (TMF) respectively in healthy participants, to inform the preparation of post-marketing labeling and the development of concomitant dosing regimens in clinical practice.

Conditions: Chronic Hepatitis B Liver Fibrosis, DDI (Drug-Drug Interaction)
Being tested: Entecavir, Tenofovir Disoproxil Fumarate（TDF）, Tenofovir alafenamide（TAF）, Tenofovir Amibufenamide(TMF)
Keywords: Hydronidone, F351

What participants receive

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

EntecavirDrug
0.5 mg, taken orally on an empty stomach, once a day
Tenofovir Disoproxil Fumarate（TDF）Drug
300 mg, taken orally on an empty stomach, once a day
Tenofovir alafenamide（TAF）Drug
25 mg, single oral dose, under fasting conditions
Tenofovir Amibufenamide(TMF)Drug
25 mg, single oral dose, under fasting conditions

Study groups in NCT07295873
Study group	Role	What they receive
Queue 1: Drug-Drug Interaction Study of Hydronidone Capsules and Entecavir	Experimental	Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions Receives: Drug: Entecavir
Queue 2: Drug-Drug Interaction Study of honyinone capsules and Tenofovir Disoproxil Fumarate;	Experimental	Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions Receives: Drug: Tenofovir Disoproxil Fumarate（TDF）
Drug-Drug Interaction Study of Fuzuloprim Capsules with Tenofovir Alafenamide	Experimental	Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions. Receives: Drug: Tenofovir alafenamide（TAF）
Queue 4: Drug-Drug Interaction Study of Hydronidone Capsules and Tenofovir Amibufenamide	Experimental	Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions. Receives: Drug: Tenofovir Amibufenamide(TMF)

What is being measured

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

Plasma hydronidone PK parameters of hydronidone capsules : steady-state peak concentration (Cmax,ss);
Measured: 23 days
Plasma hydronidone PK parametersof hydronidone capsules : Area under the plasma concentration-time curve from time zero to 24 hours at steady state (AUC0-24h,ss)
Measured: 23 days
Primary PK parameters of plasma of entecavir : AUC0-24h,ss.
Measured: 23 days
Primary PK parameters of plasma of entecavir : Cmax,ss .
Measured: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : AUC0-24h,ss.
Measured: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : Cmax,ss .
Measured: 23 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): Cmax,ss .
Measured: 20 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): AUC0-24h,ss.
Measured: 20 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : Cmax,ss .
Measured: 23 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : AUC0-24h,ss.
Measured: 23 days

Timeline

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

15 Mar 202629 May 2026

First posted22 Dec 2025
Study start15 Mar 2026
Primary completion29 May 2026
Study completion29 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis B Liver FibrosisStudies 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: Single group
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07295873
Sponsor's protocol ID: KDN-F351-202505
Status last verified: Aug 2026
First submitted: 10 Dec 2025
Last updated: 13 Aug 2026
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?

See locations

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All Chronic Hepatitis B Liver Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT07295873
Acronym / sponsor ID: KDN-F351-202505
Conditions: Chronic Hepatitis B Liver Fibrosis, DDI (Drug-Drug Interaction)
Keywords: Hydronidone, F351
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
Study start: 15 Mar 2026 (actual)
Primary completion: 29 May 2026 (actual)
Study completion: 29 May 2026 (actual)
First posted: 22 Dec 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: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Queue 1: Drug-Drug Interaction Study of Hydronidone Capsules and Entecavir	Experimental	Drug: EntecavirWithin each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions
Queue 2: Drug-Drug Interaction Study of honyinone capsules and Tenofovir Disoproxil Fumarate;	Experimental	Drug: Tenofovir Disoproxil Fumarate（TDF）Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions
Drug-Drug Interaction Study of Fuzuloprim Capsules with Tenofovir Alafenamide	Experimental	Drug: Tenofovir alafenamide（TAF）Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions.
Queue 4: Drug-Drug Interaction Study of Hydronidone Capsules and Tenofovir Amibufenamide	Experimental	Drug: Tenofovir Amibufenamide(TMF)Within each cohort, the study flow for enrolled subjects comprises three dosing periods: Period 1 consists of hydronidone capsules administered alone for 5 consecutive days; Period 2 consists of the chronic hepatitis B antiviral agent administered alone for 7 or 10 consecutive days; and Period 3 consists of concomitant administration of hydronidone capsules and the antiviral agent for 5 consecutive days. Subjects may be discharged from the study upon completion of the safety follow-up. hydronidone capsules,90 mg three times daily, under fasting conditions.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Be fully informed about the trial and demonstrate understanding of its content, procedures, and potential adverse events related to the investigational product; voluntarily provide written informed consent; and be able to comply with all study procedures and complete the study in accordance with the protocol requirements.
Male or female subjects aged 18 to 50 years, inclusive, at the time of signing informed consent.
At screening, male subjects must weigh ≥50.0 kg and female subjects must weigh ≥45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive.
At screening, all laboratory tests and related examinations (including vital signs, physical examination, 12-lead ECG, chest X-ray [PA view], abdominal ultrasound, etc.) must be within normal range or, if abnormal, determined by the investigator to be not clinically significant.

Key exclusion criteria (18 listed)

Presence of any clinically significant disease or medical history that, in the opinion of the investigator, may interfere with protocol compliance or completion of the study, including but not limited to abnormalities of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric system, or endocrine/metabolic system.
Positive results for any infectious disease screening tests at screening, including hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or Treponema pallidum antibody (TP Ab).
History of drug or food allergies, or known hypersensitivity to the active pharmaceutical ingredients of the investigational medicinal products (hydronidone, entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide) or to any of their excipients.
Participants with rare genetic disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Subjects who have experienced a clinically significant major illness within 3 months prior to screening, or have undergone surgery affecting drug absorption, distribution, metabolism, or excretion (such as gastrointestinal, hepatic, or renal surgery) or other major surgery within this period, or plan to undergo surgery during the study;

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
Entecavir0.5 mg, taken orally on an empty stomach, once a day	Drug	Queue 1: Drug-Drug Interaction Study of Hydronidone Capsules and Entecavir
Tenofovir Disoproxil Fumarate（TDF）300 mg, taken orally on an empty stomach, once a day	Drug	Queue 2: Drug-Drug Interaction Study of honyinone capsules and Tenofovir Disoproxil Fumarate;
Tenofovir alafenamide（TAF）25 mg, single oral dose, under fasting conditions	Drug	Drug-Drug Interaction Study of Fuzuloprim Capsules with Tenofovir Alafenamide
Tenofovir Amibufenamide(TMF)25 mg, single oral dose, under fasting conditions	Drug	Queue 4: Drug-Drug Interaction Study of Hydronidone Capsules and Tenofovir Amibufenamide

Primary outcome

Plasma hydronidone PK parameters of hydronidone capsules : steady-state peak concentration (Cmax,ss);
Time frame: 23 days
Plasma hydronidone PK parametersof hydronidone capsules : Area under the plasma concentration-time curve from time zero to 24 hours at steady state (AUC0-24h,ss)
Time frame: 23 days
Primary PK parameters of plasma of entecavir : AUC0-24h,ss.
Time frame: 23 days
Primary PK parameters of plasma of entecavir : Cmax,ss .
Time frame: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : AUC0-24h,ss.
Time frame: 23 days
Primary PK parameters of plasma tenofovir alafenamide (TAF) : Cmax,ss .
Time frame: 23 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): Cmax,ss .
Time frame: 20 days
Primary PK parameters of tenofovir disoproxil fumarate tablets (TDF): AUC0-24h,ss.
Time frame: 20 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : Cmax,ss .
Time frame: 23 days
Primary PK parameters of plasma tenofovir amibufenamide (TMF) : AUC0-24h,ss.
Time frame: 23 days

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 13 Aug 2026.

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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?

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 13 Aug 2026. 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?

Plasma hydronidone PK parameters of hydronidone capsules : steady-state peak concentration (Cmax,ss); (time frame: 23 days). The study lists 10 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 NCT07295873.

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 13 Aug 2026.