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
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax
Overview
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
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
Anaprazole sodium enteric-coated tablets + Rifampin capsules
Anaprazole sodium enteric-coated tablets 60 mg once daily (QD) on Day1 and D10, Rifampin capsules 600 mg QD from Day 4-Day11
Intervention: Anelazol Sodium Enteric-coated Tablets (Drug)
Anaprazole sodium enteric-coated tablets + Rifampin capsules
Anaprazole sodium enteric-coated tablets 60 mg once daily (QD) on Day1 and D10, Rifampin capsules 600 mg QD from Day 4-Day11
Intervention: Rifampicin Capsules (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The number of subjects with adverse events(From first application of study medication up to 14 days after end of treatment with study medication)