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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
60mg QD
600mg QD
Jinan Central Hospital of Shandong Province
Jinan, Shangdong, China
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
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 12
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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