Drug-drug Interaction Study of Rifampin and Anaprazole Sodium

NCT07330531 | Not Yet Recruiting Phase 4

• 1 other identifier: 3571-DDI-1007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Drug-drug Interaction Study

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  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

  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

  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

  Day 1 to Day 12

Secondary Outcomes (1)

• The number of subjects with adverse events

  From first application of study medication up to 14 days after end of treatment with study medication

Study Arms (1)

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

Drug: Anelazol Sodium Enteric-coated Tablets; Drug: Rifampicin Capsules

Interventions

Anelazol Sodium Enteric-coated Tablets DRUG

60mg QD

Anaprazole sodium enteric-coated tablets + Rifampin capsules

Rifampicin Capsules DRUG

600mg QD

Anaprazole sodium enteric-coated tablets + Rifampin capsules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital of Shandong Province

Jinan, Shangdong, 250013, China

Location

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Qing Wen, Master

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Wen, Master

CONTACT

+86-13370551767; wenq0619@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 9, 2026
• Study Start: January 4, 2026
• Primary Completion: February 5, 2026
• Study Completion (Estimated): July 21, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)