A single-center, open-label, randomized, two-sequence, two-period crossover study in 48 healthy subjects to compare the relative bioavailability of two formulations. The test (T, 0.2 g/sachet) and reference (R, 0.1 g/sachet) are administered at a dose of 0.2 g per period: sequence T-R receives 1 sachet T (period 1) and 2 sachets R (period 2); sequence R-T receives 2 sachets R (period 1) and 1 sachet T (period 2). Subjects are randomized 1:1 to either sequence.
Able to read, understand, voluntarily participate, and sign the informed consent form.
Aged 18 to 50 years (inclusive) at screening, male or female.
Body weight ≥50 kg for males and ≥45 kg for females, Body Mass Index (BMI) between 18 and 28 kg/m²^ (inclusive) [BMI = weight (kg) / height²^ (m²^)].
Vital signs, physical examination, laboratory tests, ECG, and chest X-ray (posteroanterior view) are normal or judged as abnormal without clinical significance by the investigator.
Presence of clinically significant diseases within 12 months before screening, including but not limited to digestive, circulatory, respiratory, endocrine, urinary, immune, nervous system disorders, and mental/psychological diseases.
History of any condition with bleeding risk, such as acute gastritis or gastric/duodenal ulcer.
Current history of oral ulcers, or acute or chronic infection within 1 week before screening.
Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.
Crossover
T-R (Test-Reference drug)
DrugParticipants in the T-R sequence receive 1 sachet of the test product (T) in Period 1 and 2 sachets of the reference product (R) in Period 2
R-T (Reference-Test drug)
DrugParticipants in the R-T sequence receive 2 sachets of the reference product (R) in Period 1 and 1 sachet of the test product (T) in Period 2
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (C\~max) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC\~0-t) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC\~0-∞) of the main metabolite 116-N1 after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension（Cmax）（test vs. reference）
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC0-t）（test vs. reference）
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC0-∞）（test vs. reference）
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
Primary pharmacokinetic (PK) parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension （AUC\_%Extrap）（test vs. reference）
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