The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
GP681 tablet, 20 mg, single oral dose in each Group.
GP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group.
Women and Children's hospital of Ningbo University
Ningbo, China
Maximum observed plasma concentration (Cmax)
Time frame: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration[AUC(0-T)]
Time frame: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)]
Time frame: Up to 360 hours post-dose
Time of maximum observed concentration(Tmax)
Time frame: Up to 360 hours post-dose
Apparent terminal half-life (T-HALF)
Time frame: Up to 360 hours post-dose
Incidence of adverse events (AEs)
Time frame: Up to approximately 1 month post-dose
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 1 month post-dose
Incidence of participants with vital sign abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with physical examinations abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with clinical laboratory abnormalities
Time frame: Up to approximately 1 month post-dose
Palatability Evaluation
The palatability of GP681 Powder for Oral Suspension will be evaluated to characterize and quantify the sensory attributes of the product, such as basic tastes (including bitterness, astringency, sweetness) and texture (grittiness). Overall acceptability will also be assessed.
Time frame: Up to 24 hours post-dose
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