The primary objective of this study is to evaluate the effect of Y-3 for injection on the pharmacokinetics of rosuvastatin calcium tablets (a sensitive BCRP probe substrate) in healthy participants, in order to assess the potential clinical drug-drug interaction. The results will inform the drafting of the Y-3 for injection package insert and support its safe and rational post-marketing use. The secondary objectives is to evaluate the effect of Y-3 for injection on the safety of rosuvastatin calcium tablets, and to evaluate the effect of rosuvastatin calcium tablets on the pharmacokinetics of Y-3 for injection in healthy participants.
This study is a single-center, open-label, single-arm, fixed-sequence, self-controlled study. A total of at least 20 participants (about half men and half women) will be will be enrolled and needed to complete in the study.On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning.From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days (with an infusion duration of approximately 60 minutes). On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.(with an interval of no more than 1 minute between the two administrations).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning. From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days . On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
AUC0-t of rosuvastatin
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: On Day1-4 、 Day11-15 of observation period
AUC0-∞ of rosuvastatin
Area under the concentration-time curve from time 0 to infinity (extrapolated).
Time frame: On Day1-4、Day11-15 of observation period.
Cmax of rosuvastatin
Time frame: On Day1-4、Day11-15 of observation period.
Tmax of rosuvastatin
Time frame: On Day1-4、Day11-15 of observation period.
t1/2 of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
λz of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period
AUC_%Extrap of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
Vz/F of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
CLz/F of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
AUC0-t of Y-3
Time frame: On Day9-12 of observation period
Cmax of Y-3
Time frame: On Day9-12 of observation period
Tmax of Y-3
Time frame: On Day9-12 of observation period.
The Incidence of subject getting abnormal results of clinical adverse events after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of vital signs after treatment
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The incidence of subject getting abnormal result of infusion-related reactions
Time frame: The whole study period,Day-14~day25
The Incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
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