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| Name | Class |
|---|---|
| Taichung Veterans General Hospital | OTHER |
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To evaluate pharmacokinetic profiles of Viproof Film Coated Tablets 300 mg manufactured by Yung Shin Parm. Ind. Co., Ltd., Taiwan and Viread Tablets manufactured by Patheon, Inc. in terms of plasma concentrations of tenofovir after a single oral dose of 300 mg tenofovir disoproxil fumarate in healthy subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viproof Film Coated Tablets 300mg | Experimental | Dosage form:Film-coated tablet Strength: 300 mg/tablet Dose:300 mg (one tablet, single oral dose) |
|
| Viread Tablets | Active Comparator | Dosage form:Film-coated tablet Strength: 300 mg/tablet Dose:300 mg (one tablet, single oral dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate 300 MG | Drug | One tablet of Viproof Film Coated Tablets or Viread Tablets will be orally administrated with 240 mL of water in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Area under the plasma concentration (AUC), peak concentration (Cmax), time to reach peak concentration (Tmax), elimination half-life (T1/2), total | Plasma sample: 0, 0.17, 0.33, 0.67, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and incidences | Within 1 hour before dosing, and 0.67, 12, 24, 36, 48 and 72 hours post dose |
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Inclusion Criteria:
Healthy adult male or female subjects between 20-45 years of age.
Body weight within 80-120% of ideal body weight.
Acceptable medical history and physical examination including:
Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin, glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and protein.
Females of childbearing potential practicing an acceptable method of birth control for the duration of the study.
Have signed the written informed consent to participate in the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |