Drug Drug Interaction (DDI)Phase 1NCT07457203
Study on the Drug Interaction Between Buagafuran and Voriconazole
A Phase 1 study testing Buagafuran and Voriconazole in people with Drug Drug Interaction (DDI), run by Beijing Union Pharmaceutical Factory Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction (DDI)
- What is being tested?
- Buagafuran and Voriconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
- Allergic constitution, including severe drug allergies or a history of drug allergies, known to be sensitive to experimental drugs or drugs Individuals allergic to any ingredient in the medication;
- From the screening stage to the occurrence of acute illness or concomitant medication before the study drug;
- Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;
- Researchers believe that there are other factors that are not suitable for participating in this experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Union Pharmaceutical Factory Ltd
Beijing, Beijing Municipality, 102600
Feng You, 18911123155, 18911123155@189.cn
About this study
Official title: Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants
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.
Read the detailed description
This study is a single center, non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.
The number of participants in this study is 18, and it is planned to enroll 4-6 participants for the trial first. After completing the day7 safety check, the remaining participants will enter the group.
Participants are required to take a single dose of 30 mg Buagafuran on the morning of day1 and day5. Voriconazole tablets (400 mg BID) orally on day3, and voriconazole tablets (200 mg BID) orally from day4 to day6.
- Conditions
- Drug Drug Interaction (DDI)
- Being tested
- Buagafuran, Voriconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuagafuranDrug
Also called AF-5
Buagafuran, oral administration 30mg, signal dose in the morning of day1 and day5
VoriconazoleDrug
Also called liWei@
Voriconazole tablets, oral administration 400 mg BID on day3, and Voriconazole tablets oral administration 200 mg BID from day4 to day6.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Buagafuran; Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: From day1 to day7
Secondary outcomes (1)
incidence of adverse events
To assess the safety of combination of Buagafuran and voriconazole in healthy participants.
Measured: From day1 to day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug Interaction (DDI)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Union Pharmaceutical Factory Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457203
- Sponsor's protocol ID
- BJXH-BGFN-202502
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants
- ClinicalTrials.gov ID
- NCT07457203
- Acronym / sponsor ID
- BJXH-BGFN-202502
- Conditions
- Drug Drug Interaction (DDI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing Union Pharmaceutical Factory LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 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 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.
Detailed description
This study is a single center, non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.
The number of participants in this study is 18, and it is planned to enroll 4-6 participants for the trial first. After completing the day7 safety check, the remaining participants will enter the group.
Participants are required to take a single dose of 30 mg Buagafuran on the morning of day1 and day5. Voriconazole tablets (400 mg BID) orally on day3, and voriconazole tablets (200 mg BID) orally from day4 to day6.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buagafuran+Voriconazole | Experimental | Drug: Buagafuran, Drug: VoriconazoleParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.);
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-5Buagafuran, oral administration 30mg, signal dose in the morning of day1 and day5 | Drug | Buagafuran+Voriconazole |
| VoriconazoleAlso: liWei@Voriconazole tablets, oral administration 400 mg BID on day3, and Voriconazole tablets oral administration 200 mg BID from day4 to day6. | Drug | Buagafuran+Voriconazole |
Primary outcome
Pharmacokinetics of Buagafuran（ Cmax）
Time frame: From day1 to day7
To evaluate the potential effect of multiple oral doses of Voriconazole on the single-dose PK of Buagafuran. Maximum observed concentration (Cmax).
Pharmacokinetics of Buagafuran (AUC0-inf)
Time frame: From day1 to day7
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.
Pharmacokinetics of Buagafuran (AUC0-t)
Time frame: From day1 to day7
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.
1 secondary outcome
incidence of adverse events
Time frame: From day1 to day7
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 and Voriconazole in people with Drug Drug Interaction (DDI), 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 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: opening soon, as of the sponsor's last update on 9 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 day7). 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 9 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.