Study on the Drug Interaction Between Buagafuran and Voriconazole

NCT07457203 | Not Yet Recruiting Phase 1

• 1 other identifier: BJXH-BGFN-202502
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.The research period is 7 days in total.

Conditions

Drug Drug Interaction (DDI)

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of Buagafuran（ Cmax）

  To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran. Maximum observed concentration (Cmax).

  From day1 to day7

• Pharmacokinetics of Buagafuran (AUC0-inf)

  To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-inf) from time zero to infinity.

  From day1 to day7

• Pharmacokinetics of Buagafuran (AUC0-t)

  To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran.Area under the concentration-time curve (AUC0-t) time zero to last quantifiable concentration.

  From day1 to day7

Secondary Outcomes (1)

• incidence of adverse events

  From day1 to day7

Study Arms (1)

Buagafuran+Voriconazole

EXPERIMENTAL

Participants took a single dose of 30 mg of Buagafuran capsules on day1 and day5; voriconazole tablets (400 mg, BID) on day3, and voriconazole tablets (200 mg, BID) from day4 to day6.

Drug: Buagafuran; Drug: Voriconazole

Interventions

Buagafuran DRUG

Buagafuran, oral administration 30mg, signal dose in the morning of day1 and day5

Also known as: AF-5

Buagafuran+Voriconazole

Voriconazole DRUG

Voriconazole tablets, oral administration 400 mg BID on day3, and Voriconazole tablets oral administration 200 mg BID from day4 to day6.

Also known as: liWei@

Buagafuran+Voriconazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily sign an informed consent form before the start of activities related to this experiment and be able to understand the procedures of this experiment Willing to strictly adhere to the clinical trial protocol and complete this trial in accordance with the method;
• Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the investigational drug, and voluntarily adopt highly effective contraceptive measures (specific contraceptive measures can be found in Appendix 1);
• On the day of signing the informed consent form, the age range is 18 to 45 years old (including both ends), and both males and females are eligible;
• Male participants weighing no less than 50 kg and female participants weighing no less than 45 kg; Body Mass Index (BMI)19-28 kg/m2 (including both ends), body mass index (BMI)=weight (kg)/height 2 (m2);
• Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 80 mL/min.

You may not qualify if:

• Screening period physical examination, vital sign examination, 12 lead electrocardiogram, clinical laboratory examination (blood routine Abnormal and clinically significant factors such as blood biochemistry, urine routine, coagulation function, etc. have been identified by researchers;
• Clinical findings indicate the presence of the following diseases: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, and endocrine disorders Secretory, tumor, lung, immune, psychiatric or cardiovascular diseases that the researcher deems unsuitable to participate in this study Researcher;
• Any potential impact on the safety of the trial or drug absorption, distribution, metabolism, or excretion within the first 6 months of screening Individuals with a history of surgery or trauma, or those planning to undergo surgery during the study period;
• History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent malignant events caused by any underlying cause Individuals with a history of heart or vomiting;
• Individuals with a history of eye diseases (such as retinal hemorrhage, optic nerve abnormalities, etc.);
• Individuals with previous risk factors for arrhythmia, such as congenital or acquired QTc interval prolongation, cardiomyopathy, and menstrual disorders Researchers have identified clinically significant abnormalities such as sinus bradycardia;
• Participate in blood donation within 3 months prior to screening and donate ≥ 400 mL (excluding female menstrual bleeding), or Blood transfusion recipients;
• Screening for use of other clinical trial drugs within the first 3 months or planned participation in other clinical trials during the study period The person;
• Individuals with a history of drug abuse, drug dependence, drug use, or urinary drug abuse within the past 5 years prior to screening Individuals with positive screening results;
• Individuals with a history of alcohol abuse or those who have frequently consumed alcohol within the past 6 months, i.e. those who consume ≥ 14 units of alcohol per week (1 Unit=360 mL of beer with an alcohol content of 5%, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of alcohol 12% wine), or any alcoholic product taken on the day before the first dose, or alcohol blowing Individuals who test positive for alcohol or are unable to stop consuming alcohol during the study period;
• Excessive smoking (≥ 5 cigarettes/day) within the first 3 months of screening, or inability to stop smoking during the trial period;
• Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody or syphilis antibody;
• Used any drugs that affect liver enzymes within the previous month (or 5 times half-life, whichever is longer) before screening Active drugs (including inhibitors and inducers that affect metabolic enzymes);
• Within 14 days prior to the first use of the investigational drug, any prescription, over-the-counter, herbal, or herbal medicine has been used Health products (excluding topical preparations that exert local effects);
• Consuming grapefruit or products containing grapefruit, caffeine, and yellow within 48 hours prior to taking the investigational drug Foods or beverages containing purines or alcohol (including chocolate, tea, coffee, cola, etc.); Intense exercise, or Those who have other factors that affect drug absorption, distribution, metabolism, excretion, etc;

Sponsors & Collaborators

• Beijing Union Pharmaceutical Factory Ltd: lead

Study Sites (1)

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, 102600, China

Location

MeSH Terms

Interventions

buagafuran; Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hong Zhang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng You

CONTACT

86+18911123155; 18911123155@189.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)