Generalized Anxiety DisorderPhase 1NCT07457190

Pharmacokinetic Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function

A Phase 1 study testing Buagafuran in people with Generalized Anxiety Disorder, run by Beijing Union Pharmaceutical Factory Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Generalized Anxiety Disorder
What is being tested?: Buagafuran
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: Mar 2026to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial;
Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the study drug, and voluntarily adopt highly effective contraceptive measures;
On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), and both males and females are eligible;
Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg; Body Mass Index (BMI) should be between 18 and 32 kg/m2 (including both ends), with BMI=weight (kg)/height (m2);
Creatinine clearance rate ≥ 60 mL/min;
Participants with normal hepatic function must also meet all of the following criteria: a): Weight matching with the hepatic impairment group, with an average weight range of ± 10 kg; b): Age matching with the hepatic impairment group, with an average age range of ± 10 years; c): The number of participants of each gender is similar to that of the hepatic impairment group (mean ± 1 participant/gender);
Participants with hepatic impairment must also meet all of the following conditions: a): Chronic hepatic impairment caused by primary hepatic diseases, and hepatic impairment patients with Child Pugh classification of A or B; b):The clinical diagnosis is cirrhosis; c): Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment; or those who have not taken medication;

Who cannot join

Allergic constitution, including individuals with a history of severe drug allergies or drug hypersensitivity reactions, known to be allergic to the study drug or any component of the study drug;
During the screening period, the electrocardiogram showed a QTc interval of>470 milliseconds in males and>480 milliseconds in females;
Individuals with a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent nausea or vomiting caused by any underlying cause;
Those who need treatment for bacterial, viral, parasitic or fungal infection with any clinical symptoms during screening (excluding hepatitis B and hepatitis C), and those who have a history of serious active infection within 1 month before screening;
Individuals who have undergone major surgeries within the previous 6 months (defined as surgeries involving intracranial, chest, abdominal, pelvic, or limb organs that cause significant tissue trauma and require long-term recovery (such as organ transplantation, heart surgery, or joint replacement), or those who plan to undergo surgery during the study period; Individuals with a history of liver transplantation; Participants who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion in the past (such as gastric and duodenal resection surgery) or who may be hospitalized due to surgery or other reasons during the expected trial period;
Screening individuals who have received the vaccine within the previous 14 days or plan to receive the vaccine during the study period;

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Screening individuals who have donated blood or lost blood ≥ 200 mL within the first 3 months, or plan to donate blood during the trial period or within 1 month after the trial ends;
Screening for individuals who have used other clinical trial drugs within the previous 3 months or plan to participate in other clinical trials during the study period;
Within one month prior to screening (or 5 times the half-life, whichever is longer), strong or moderate inducers or inhibitors of CYP2B6, CYP3A4, renal transporter inhibitors, etc. have been used;
Consuming grapefruit or products containing grapefruit, food or beverages containing caffeine, xanthine, or alcohol (including chocolate, tea, coffee, cola, etc) 48 hours prior to receiving the investigational drug; Those who engage in vigorous exercise or have other factors that affect drug absorption, distribution, metabolism, excretion, etc;
Screening for alcoholics within the first 3 months, those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine) or have a positive alcohol screening result; Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening;
Individuals with a history of drug use, drug abuse, or positive drug abuse screening;
Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;
Those who cannot tolerate venipuncture or have a history of needle and blood dizziness;
Other reasons why researchers believe it is not suitable for inclusion;
Participants with normal hepatic function who meet any of the following exclusion criteria need to be excluded:
History of hepatic impairment;
Individuals who have previously or currently suffered from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that may interfere with the test results;
Abnormal physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, abdominal ultrasound and other examinations have clinical significance as determined by the researchers;
Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody or syphilis antibody;
Have used any prescription drugs, over-the-counter drugs, herbal medicines, or supplements within 14 days prior to receiving the investigational drug.
Participants with hepatic impairment who meet any of the following exclusion criteria must be excluded:
Participants have any of the following conditions: acute hepatic function damage caused by various reasons; History of liver transplantation; And researchers believe that patients with liver cirrhosis complicated with the following complications: including but not limited to hepatic failure, hepatic encephalopathy, hepatocellular carcinoma (excluding liver cancer patients who have received curative treatment and have not relapsed; excluding liver cancer patients with BCLC stage 0), and those who have experienced esophageal and gastric variceal bleeding within the past 3 months before screening;
The laboratory test results during screening meet any of the following criteria: (a) ALT or AST>10 × ULN; (b) NE#<0.75×109/L；(c) HGB<60 g/L； (d) AFP>100 ng/mL; (e) Platelet count<40 × 109/L; any remaining abnormalities that have clinical significance and have been determined by the researchers to be unsuitable for participation in this trial;
Individuals who test positive for HIV antigen/antibody screening; If syphilis antibodies are positive, rapid plasma reagin (RPR) testing should be added. If RPR is also positive, it should be excluded;
In addition to the primary liver disease itself, those who have previously or currently suffered from other serious organ systemic diseases, including but not limited to gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or abnormalities with clinical significance such as physical examination and chest radiograph, and have been determined by the research doctor to be unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Feng You contact

86+18911123155

18911123155@189.cn

China1 site

Beijing Union Pharmaceutical Factory Ltd
Beijing, Beijing Municipality, 102600
Feng You, 86+18911123155, 18911123155@189.cn

Other trials in China

About this study

Official title: Pharmacokinetic and Safety Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.

Read the detailed description

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.

This study enrolled 24 participants, both male and female. Three experimental groups were set up, with Day1 taking 30 mg Buagafuran capsules on an empty stomach in the morning.Participants can leave on Day3.

Conditions: Generalized Anxiety Disorder
Being tested: Buagafuran
Medical subject headings: Generalized Anxiety Disorder

What participants receive

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

BuagafuranDrug
Also called AF-5
participants to receive Buagafuran capsules 30 mg on an empty stomach on the morning of Day1

Study groups in NCT07457190
Study group	Role	What they receive
Child-Pugh A	Experimental	participants with Mild Hepatic Impairment: All participants to receive study drug (Buagafuran 30mg) on Day 1 Receives: Drug: Buagafuran
Child-Pugh B	Experimental	Participants with Moderate Hepatic Impairment: All participants to receive study drug (Buagafuran 30mg) on Day 1 Receives: Drug: Buagafuran
Normal Hepatic Function	Experimental	participants with Normal Hepatic Function: All participants to receive study drug (Buagafuran 30mg) on Day 1 Receives: Drug: Buagafuran

What is being measured

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

Pharmacokinetics of Buagafuran(Cmax)
Maximum observed plasma concentration
Measured: from Day1 to Day3
Pharmacokinetics of Buagafuran(AUC0-t)
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Measured: from Day1 to Day3
Pharmacokinetics of Buagafuran(AUC0-inf)
Area under the plasma concentration-time curve from time 0 to infinity
Measured: from Day1 to Day3

Secondary outcomes (1)

incidence of Adverse Events
To evaluate the safety of a single dose of 30mg Buagafuran administered in participants with hepatic impairment
Measured: from Day1 to Day3

Timeline

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

Mar 2026Dec 2026

First posted9 Mar 2026
Study startMar 2026 (estimated)
Primary completionAug 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Generalized Anxiety DisorderStudies 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07457190
Sponsor's protocol ID: BJXH-BGFN-202501
Status last verified: Feb 2026
First submitted: 26 Feb 2026
Last updated: 10 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Feng You

86+18911123155

18911123155@189.cn

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 sites and contacts

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All Generalized Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic and Safety Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function
ClinicalTrials.gov ID: NCT07457190
Acronym / sponsor ID: BJXH-BGFN-202501
Conditions: Generalized Anxiety Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Beijing Union Pharmaceutical Factory LtdIndustry (pharma, biotech, devices)
Study start: Mar 2026 (estimated)
Primary completion: Aug 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 9 Mar 2026 (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.

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.

Detailed description

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Child-Pugh A	Experimental	Drug: Buagafuranparticipants with Mild Hepatic Impairment: All participants to receive study drug (Buagafuran 30mg) on Day 1
Child-Pugh B	Experimental	Drug: BuagafuranParticipants with Moderate Hepatic Impairment: All participants to receive study drug (Buagafuran 30mg) on Day 1
Normal Hepatic Function	Experimental	Drug: Buagafuranparticipants with Normal Hepatic Function: All participants to receive study drug (Buagafuran 30mg) on Day 1

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial;
Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the study drug, and voluntarily adopt highly effective contraceptive measures;
On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), and both males and females are eligible;
Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg; Body Mass Index (BMI) should be between 18 and 32 kg/m2 (including both ends), with BMI=weight (kg)/height (m2);
Creatinine clearance rate ≥ 60 mL/min;

Key exclusion criteria (26 listed)

Allergic constitution, including individuals with a history of severe drug allergies or drug hypersensitivity reactions, known to be allergic to the study drug or any component of the study drug;
During the screening period, the electrocardiogram showed a QTc interval of>470 milliseconds in males and>480 milliseconds in females;
Individuals with a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent nausea or vomiting caused by any underlying cause;
Those who need treatment for bacterial, viral, parasitic or fungal infection with any clinical symptoms during screening (excluding hepatitis B and hepatitis C), and those who have a history of serious active infection within 1 month before screening;
Individuals who have undergone major surgeries within the previous 6 months (defined as surgeries involving intracranial, chest, abdominal, pelvic, or limb organs that cause significant tissue trauma and require long-term recovery (such as organ transplantation, heart surgery, or joint replacement), or those who plan to undergo surgery during the study period; Individuals with a history of liver transplantation; Participants who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion in the past (such as gastric and duodenal resection surgery) or who may be hospitalized due to surgery or other reasons during the expected trial period;

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
BuagafuranAlso: AF-5participants to receive Buagafuran capsules 30 mg on an empty stomach on the morning of Day1	Drug	Child-Pugh A, Child-Pugh B, Normal Hepatic Function

Primary outcome

Pharmacokinetics of Buagafuran(Cmax)
Time frame: from Day1 to Day3
Maximum observed plasma concentration
Pharmacokinetics of Buagafuran(AUC0-t)
Time frame: from Day1 to Day3
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Pharmacokinetics of Buagafuran(AUC0-inf)
Time frame: from Day1 to Day3
Area under the plasma concentration-time curve from time 0 to infinity

1 secondary outcome

incidence of Adverse Events
Time frame: from Day1 to Day3

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Generalized Anxiety Disorder

Recruiting
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Mental Health and General Well-being
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Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
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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.

Feng You contact

86+18911123155

18911123155@189.cn

Hong Zhang principal investigator

The First Hospital of Jilin University

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 Buagafuran in people with Generalized Anxiety Disorder, run by Beijing Union Pharmaceutical Factory 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 7 inclusion and 26 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: opening soon, as of the sponsor's last update on 10 Mar 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Feng You (86+18911123155, 18911123155@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of Buagafuran(Cmax) (time frame: from Day1 to Day3). 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 NCT07457190.

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 10 Mar 2026.