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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.
This is a single-center, open-label, randomized, two-sequence, two-period crossover study to assess the relative bioavailability of two formulations. The test product (T) is the 0.2 g/sachet formulation, and the reference product (R) is the 0.1 g/sachet formulation. The formulations are not identical. The study plans to enroll 48 healthy participants, male and female, who will be randomized in a 1:1 ratio to two dosing sequences (T-R and R-T), with 24 participants per sequence. The administered dose per period is 0.2 g for both T and R. Participants 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. Participants 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIM0916(0.2 g) | Experimental |
| |
| SIM0916(0.1g) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-R (Test-Reference drug) | Drug | Participants 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to Day10 |
| 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) | From enrollment to Day10 |
| 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) | From enrollment to Day10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to Day10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhibiao song | Contact | +8602585566666 | songzhibiao@simcere.com |
| Name | Affiliation | Role |
|---|---|---|
| xiaojiao Li | The First Hospital of Jilin University | Principal Investigator |
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| R-T (Reference-Test drug) | Drug | Participants 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 |
|
| 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) | From enrollment to Day10 |
| 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) | From enrollment to Day10 |
| 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) | From enrollment to Day10 |
| 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 (Tmax)(test vs. reference) | From enrollment to Day10 |
| 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 (t1/2)(test vs. reference) | From enrollment to Day10 |