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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence T-R | Experimental |
| |
| Treatment sequence R-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP681 tablet | Drug | GP681 tablet, 20 mg, single oral dose in each Group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | 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)] | Up to 360 hours post-dose | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)] | Up to 360 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed concentration(Tmax) | Up to 360 hours post-dose | |
| Apparent terminal half-life (T-HALF) | Up to 360 hours post-dose | |
| Incidence of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Children's hospital of Ningbo University | Ningbo | China |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| GP681 Powder for Oral Suspension | Drug | GP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group. |
|
|
| Up to approximately 1 month post-dose |
| Incidence of serious adverse events (SAEs) | Up to approximately 1 month post-dose |
| Incidence of participants with vital sign abnormalities | Up to approximately 1 month post-dose |
| Incidence of participants with physical examinations abnormalities | Up to approximately 1 month post-dose |
| Incidence of participants with electrocardiogram (ECG) abnormalities | Up to approximately 1 month post-dose |
| Incidence of participants with clinical laboratory abnormalities | 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. | Up to 24 hours post-dose |