This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.
The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd
Pharmacokinetic(PK) parameters
Time frame: Up to 17 days
Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg
PK parameters
Time frame: Up to 17 days
Area under the plasma concentration versus time curve (AUC) of ABT following ABT 320mg administration with and without RIF 600mg qd
PK parameters
Time frame: Up to 17 days
Area under the plasma concentration versus time curve (AUC) of RIF 600mg qd administration with and without ABT 320mg
PK parameters
Time frame: Up to 17 days
Number of subjects with abnormal findings for laboratory parameters
Number of subjects with Grade 3/4 laboratory parameters
Time frame: Up to 17 days
Number of subjects with adverse events.
An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time frame: Up to 17 days
Number of subjects with severity of adverse events
The Division of AIDS table for grading the severity of adult and pediatric adverse events will be used to assess severity.
Time frame: Up to 17 days
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