Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Anelazol Sodium Enteric-coated Tablets

    Drug

    60mg QD

  • Rifampicin Capsules

    Drug

    600mg QD

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Anaprazole sodium enteric-coated tablets + Rifampin capsulesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 to Day 12
2

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

Time frame
Day 1 to Day 12
3

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

Time frame
Day 1 to Day 12
4

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

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanzhu Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: