A single center, open-label, single sequence study was conducted to evaluate the potential drug interaction of CYP3A4 inducer rifampicin with SY-004 capsules in healthy subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
On the morning of D1, the subjects will take orally 80 mg of SY-004 Capsules on an empty stomach.Fasting will be performed within 4 hours after taking the medicine. From D8 to D14, the subjects will take orally 600 mg rifampicin before breakfast every day. On the day of D15, the subjects will take orally 600 mg rifampicin and 80 mg SY-004 Capsules on an empty stomach. From D16 to D21, subjects will take orally 600 mg of rifampicin before breakfast every day.The patient can be discharged from the hospital after completing the safety examination on D22.
XIE Haitang
Wuhu, Anhui, China
Cmax
Peak Plasma Concentration (Cmax) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
AUC0-t
Area under the plasma concentration versus time curve (AUC0-t)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
AUC0-∞
Area under the plasma concentration versus time curve (AUC0-∞)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
Tmax
Peak Time (Tmax)of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
T1/2z
Half time (T1/2z)of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
CLz/F
Clearance (Clz/F)of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Time frame: 22 days
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