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Drug-drug Interaction Study of Rifampin and Anaprazole Sodium | Clinical Trials | Clareo Health

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Drug-drug Interaction Study of Rifampin and Anaprazole Sodium

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

NCT07330531•Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male or female subjects aged 18-45 years (including boundary values);
•2. Male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m2 (including boundary value);
•3. No mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, history of systemic, endocrine and metabolic abnormalities;
•4. 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;
•5. 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.

Exclusion Criteria

•1. 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;
•2. 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;
•3. 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;
•4. 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;
•5. Alcohol breath test positive o regular drinkers within 6 months before screening, drinking more than 14 units per week \[1 unit is equivalent to 350 mL of beer (5%), 45 mL of spirits (40%) or 150 mL of wine (12%)\];
•6. 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;
•7. Participated in other clinical trials and used investigational drugs within 3 months before screening;
•8. 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;
•9. 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;
•10. 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;
+8 more criteria

Locations (1)

Jinan Central Hospital of Shandong Province

Jinan, Shangdong, China

Key Dates

Start Date

January 4, 2026

Primary Completion Date

February 5, 2026

Completion Date

July 21, 2027

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

Drug-drug Interaction Study

Interventions

Anelazol Sodium Enteric-coated Tablets

DRUG

Rifampicin Capsules

DRUG

Contacts

Qing Wen, Master

CONTACT

+86-13370551767 wenq0619@126.com

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

NCT02227173

Drug-drug Interaction Study

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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