The goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
This is a single-center, randomized, open-label, two-period, crossover clinical study to evaluate the bioavailability of two specifications of oral deuteriumremidvir hydrobromide for suspension. With a washout period of 3 days, the dose is 200 mg in each sequence. The specification of the test formulation(T) is 200 mg and that for the reference formulation (R) is 100 mg. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).
Participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).
The First Affiliated Hospital of Bengbu Medical College
Xuzhou, Jiangsu, China
Cmax
maximum observed plasma concentration
Time frame: 48 hours after administration
AUC0-t
area under the plasma concentration time curve from time zero to the last measurable concentration
Time frame: 48 hours after administration
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Time frame: 48 hours after administration]
AUC0-24h
area under the plasma concentration-time curve from 0 to 24 hours
Time frame: 24 hours after administration
Tmax
time at which Cmax occurs
Time frame: 48 hours after administration
Tlag
time lag
Time frame: 48 hours after administration
t1/2
half life of elimination
Time frame: 48 hours after administration
CLz/F
apparent clearance
Time frame: 48 hours after administration
Vz/F
apparent volume of distribution during the terminal phase
Time frame: 48 hours after administration
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λz
first-order rate constant associated with the terminal (log-linear) portion of the curve
Time frame: 48 hours after administration
MRT
mean residence time
Time frame: 48 hours after administration
AE & SAE
Adverse event \& serious adverse events
Time frame: from day1 to day6 after administration