Drug-drug Interaction StudyPhase 4NCT07330531
Drug-drug Interaction Study of Rifampin and Anaprazole Sodium
A Phase 4 study testing Anelazol Sodium Enteric-coated Tablets and Rifampicin Capsules in people with Drug-drug Interaction Study, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A drug-drug interaction study designed to evaluate the drug-drug interaction between rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects 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 Study
- What is being tested?
- Anelazol Sodium Enteric-coated Tablets and Rifampicin Capsules
- 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
- 4 Jan 2026to 21 Jul 2027
- Phase
- Phase 4
- 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
- Healthy male or female subjects aged 18-45 years (including boundary values);
- Male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m2 (including boundary value);
- No mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, history of systemic, endocrine and metabolic abnormalities;
- The subjects agreed to use effective contraception and had no plans to donate sperm or eggs from the time of trial screening until 6 months after the last dose;
- The subjects should be able to communicate well with the researchers, understand and comply with the requirements of the study, and understand and sign the informed consent.
Who cannot join
- Subjects with a specific allergic history (e.g., urticaria, eczema), an allergic constitution (e.g., allergy to two or more drugs, foods such as milk or pollen), a known allergy to anaprazole sodium or similar drugs, or an allergy to rifampin or its similar antibacterial drugs;
- During screening, there are clinical significant abnormal results in physical examination, laboratory tests, 12-lead electrocardiogram, chest x-ray examination or abdomen B ultrasound examination;
- Subjects with a history of drug abuse (including regular use of sedatives, hypnotics, or other addictive substances) within 12 months before screening; or who have used illicit drugs; or test positive in urine drug screening;
- Subjects who smoked more than 5 cigarettes per day within the 3 months before screening, or who could not stop using any tobacco products during the study;
- Alcohol breath test positive o regular drinkers within 6 months before screening, drinking more than 14 units per week [1 unit is equivalent to 350 mL of beer (5%), 45 mL of spirits (40%) or 150 mL of wine (12%)];
- Use any prescription drugs or traditional Chinese medicine within 4 weeks prior to the first dose, or use any OTC drugs or dietary supplements within 2 weeks before the first dose;
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- Participated in other clinical trials and used investigational drugs within 3 months before screening;
- Those who received live vaccine within 2 weeks before the first dose, or planned to receive live vaccine during the study or within 7 days after the study was completed;
- Blood donation (including component blood donation) or blood loss of 400 mL within 3 months before screening, or blood transfusion; Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before screening;
- Have a history of major disease, major surgery, or significant trauma within the 3 months prior to screening, or who plan to undergo surgery during the study;
- Subjects with dysphagia or a history of gastrointestinal disorders that may affect drug absorption or cause clinically significant symptoms (e.g., gastrectomy or small bowel resection, atrophic gastritis, chronic intestinal diseases, gastrointestinal bleeding, obstruction, etc.), or those with acute gastrointestinal conditions (such as nausea, vomiting, diarrhea, abdominal pain, constipation, etc.) within the week prior to screening;
- Female subjects during pregnancy and lactation and female subjects of reproductive age who cannot take contraception as required;
- HBsAg, HCV Ab, Treponema pallidum antibody, HIV Ab test results are positive;
- Those who have special dietary requirements (including lactose intolerance) and are unable to comply with the provided diet and corresponding regulations;
- Those who have consumed a special diet (including pitaya, mango, pomelo, and/or xanthine-containing foods, chocolate) and/or have regularly consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day, with each cup being 200 mL) within the 2 weeks prior to the first dose, thereby potentially affecting drug absorption, distribution, metabolism, or excretion;
- Use of any drug that inhibits or induces hepatic metabolism within 30 days prior to the first dose: Inducer such as barbiturates, carbamazepine, phenytoin sodium, rifamequine; Inhibitors such as cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrroles, etc.);
- Those who cannot tolerate blood collection by venipuncture or whose blood vessels are in poor condition;
- Other subjects deemed unsuitable to participate in the study by the investigator.
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
Jinan Central Hospital of Shandong Province
Jinan, Shangdong, 250013
Qing Wen, Master, +86-13370551767, wenq0619@126.com
Qing Wen, Master
About this study
Official title: A Drug-drug Interaction Study to Evaluate the Effects of Rifampin Capsules on the Pharmacokinetics of Anaprazole Sodium Enteric-coated Tablets in Healthy Adult Subjects
A drug-drug interaction study designed to evaluate the drug-drug interaction between rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects
Read the detailed description
This is an open-label, single-center, two-period, single-sequence crossover drug-drug interaction study of rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects. On Day 1 and Day 10, subjects will orally receive a single 60 mg dose of anaprazole sodium enteric-coated tablets in the morning under fasting conditions. From Day 4 to Day 11, subjects will orally receive 600 mg of rifampin capsules once daily (QD) in the morning under fasting conditions for 8 consecutive days. Specifically, on Day 10, subjects will orally receive both a single 60 mg dose of anaprazole sodium enteric-coated tablets and a 600 mg dose of rifampin capsules in the morning under fasting conditions. Pharmacokinetics will be followed from Day 1 through Day 12.
- Conditions
- Drug-drug Interaction Study
- Being tested
- Anelazol Sodium Enteric-coated Tablets, Rifampicin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anelazol Sodium Enteric-coated TabletsDrug
60mg QD
Rifampicin CapsulesDrug
600mg QD
| Study group | Role | What they receive |
|---|---|---|
| Anaprazole sodium enteric-coated tablets + Rifampin capsules | Experimental | Anaprazole sodium enteric-coated tablets 60 mg once daily (QD) on Day1 and D10, Rifampin capsules 600 mg QD from Day 4-Day11 Receives: Drug: Anelazol Sodium Enteric-coated Tablets; Drug: Rifampicin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To assess the effects of multiple oral dose administration of rifampin on the Cmax of the parent drug and major metabolites of anaprazole sodium in healthy subjects.
Measured: Day 1 to Day 12
AUC0-t
To assess the effects of multiple oral dose administration of rifampin on the AUC0-t of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
AUC0-∞
To assess the effects of multiple oral dose administration of rifampin on the AUC0-∞ of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
Tmax
To assess the effects of multiple oral dose administration of rifampin on the Tmax of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
t1/2
To assess the effects of multiple oral dose administration of rifampin on the t1/2 of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
CL/F
To assess the effects of multiple oral dose administration of rifampin on the CL/F of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
V/F
To assess the effects of multiple oral dose administration of rifampin on the V/F of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Measured: Day 1 to Day 12
Secondary outcomes (1)
The number of subjects with adverse events
To evaluate the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of anaprazole sodium administered alone and in combination with rifampin in healthy subjects.
Measured: From first application of study medication up to 14 days after end of treatment with study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start4 Jan 2026 (estimated)
- Primary completion5 Feb 2026 (estimated)
- Study completion21 Jul 2027 (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 StudyStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Master, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330531
- Sponsor's protocol ID
- 3571-DDI-1007
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-drug Interaction Study to Evaluate the Effects of Rifampin Capsules on the Pharmacokinetics of Anaprazole Sodium Enteric-coated Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07330531
- Acronym / sponsor ID
- 3571-DDI-1007
- Conditions
- Drug-drug Interaction Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2026 (estimated)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 21 Jul 2027 (estimated)
- First posted
- 9 Jan 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.
A drug-drug interaction study designed to evaluate the drug-drug interaction between rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects
Detailed description
This is an open-label, single-center, two-period, single-sequence crossover drug-drug interaction study of rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects. On Day 1 and Day 10, subjects will orally receive a single 60 mg dose of anaprazole sodium enteric-coated tablets in the morning under fasting conditions. From Day 4 to Day 11, subjects will orally receive 600 mg of rifampin capsules once daily (QD) in the morning under fasting conditions for 8 consecutive days. Specifically, on Day 10, subjects will orally receive both a single 60 mg dose of anaprazole sodium enteric-coated tablets and a 600 mg dose of rifampin capsules in the morning under fasting conditions. Pharmacokinetics will be followed from Day 1 through Day 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaprazole sodium enteric-coated tablets + Rifampin capsules | Experimental | Drug: Anelazol Sodium Enteric-coated Tablets, Drug: Rifampicin CapsulesAnaprazole sodium enteric-coated tablets 60 mg once daily (QD) on Day1 and D10, Rifampin capsules 600 mg QD from Day 4-Day11 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects aged 18-45 years (including boundary values);
- Male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m2 (including boundary value);
- No mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, history of systemic, endocrine and metabolic abnormalities;
- The subjects agreed to use effective contraception and had no plans to donate sperm or eggs from the time of trial screening until 6 months after the last dose;
- The subjects should be able to communicate well with the researchers, understand and comply with the requirements of the study, and understand and sign the informed consent.
Key exclusion criteria (18 listed)
- Subjects with a specific allergic history (e.g., urticaria, eczema), an allergic constitution (e.g., allergy to two or more drugs, foods such as milk or pollen), a known allergy to anaprazole sodium or similar drugs, or an allergy to rifampin or its similar antibacterial drugs;
- During screening, there are clinical significant abnormal results in physical examination, laboratory tests, 12-lead electrocardiogram, chest x-ray examination or abdomen B ultrasound examination;
- Subjects with a history of drug abuse (including regular use of sedatives, hypnotics, or other addictive substances) within 12 months before screening; or who have used illicit drugs; or test positive in urine drug screening;
- Subjects who smoked more than 5 cigarettes per day within the 3 months before screening, or who could not stop using any tobacco products during the study;
- Alcohol breath test positive o regular drinkers within 6 months before screening, drinking more than 14 units per week [1 unit is equivalent to 350 mL of beer (5%), 45 mL of spirits (40%) or 150 mL of wine (12%)];
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 |
|---|---|---|
| Anelazol Sodium Enteric-coated Tablets60mg QD | Drug | Anaprazole sodium enteric-coated tablets + Rifampin capsules |
| Rifampicin Capsules600mg QD | Drug | Anaprazole sodium enteric-coated tablets + Rifampin capsules |
Primary outcome
Cmax
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the Cmax of the parent drug and major metabolites of anaprazole sodium in healthy subjects.
AUC0-t
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the AUC0-t of the parent drug and major metabolites of anaprazole sodium in healthy subjects
AUC0-∞
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the AUC0-∞ of the parent drug and major metabolites of anaprazole sodium in healthy subjects
Tmax
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the Tmax of the parent drug and major metabolites of anaprazole sodium in healthy subjects
t1/2
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the t1/2 of the parent drug and major metabolites of anaprazole sodium in healthy subjects
CL/F
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the CL/F of the parent drug and major metabolites of anaprazole sodium in healthy subjects
V/F
Time frame: Day 1 to Day 12
To assess the effects of multiple oral dose administration of rifampin on the V/F of the parent drug and major metabolites of anaprazole sodium in healthy subjects
1 secondary outcome
The number of subjects with adverse events
Time frame: From first application of study medication up to 14 days after end of treatment with study medication
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 Jan 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.
Qing Wen, Master principal investigator
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anelazol Sodium Enteric-coated Tablets and Rifampicin Capsules in people with Drug-drug Interaction Study, run by Xuanzhu Biopharmaceutical 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 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: opening soon, as of the sponsor's last update on 9 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Qing Wen, Master (+86-13370551767, wenq0619@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1 to Day 12). The study lists 7 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 Jan 2026.