Drug-drug Interaction Study of Rifampin and Anaprazole Sodium
ConditionDrug-drug Interaction Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorXuanzhu Biopharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Anelazol Sodium Enteric-coated Tablets
- Rifampicin Capsules
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov