The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
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