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This study evaluated the bioequivalence and safety of the test formulation (Tenofovir Disoproxil Fumarate Tablets, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (Viread®, Gilead Sciences, Inc.) in healthy Chinese subjects under fasting and fed conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formulation (Test Tenofovir Disoproxil Fumarate Tablets) | Experimental | Tenofovir Disoproxil Fumarate Tablets (300 mg/table) Manufacturer: Haisco Pharmaceutical Group Co., Ltd |
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| Reference formulation (Viread®) | Experimental | Tenofovir Disoproxil Fumarate Tablets (Viread®,300 mg/table) Manufacturer: Gilead Sciences, Inc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Tenofovir Disoproxil Fumarate Tablets | Drug | Test formulation(Tenofovir Disoproxil Fumarate Tablets,Haisco Pharmaceutical Group Co., Ltd),A single oral dose of 300 mg, taken with 240mL of water |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum blood concentration, the pharmacokinetic parameters of tenofovir in plasma | From the start of administration to 72 hours post-dose |
| AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t) | The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of tenofovir in plasma | From the start of administration to 72 hours post-dose |
| AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity) | The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of tenofovir in plasma | From the start of administration to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AEs (Adverse events) | The incidence and severity of adverse events | From the time of signing ICF (Informed Consent Form) to the end of follow-up,up to 10 days |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Shenyang Military Region | Shenyang | China |
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| Reference Tenofovir Disoproxil Fumarate Tablets(Viread®) | Drug | Reference formulation(Viread®,Gilead Sciences, Inc.)A single oral dose of 300 mg, taken with 240mL of water |
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