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A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole in Healthy Volunteers Under Fasting Conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaway Lyo-Injection | Experimental | Voriconazole, 200 mg/vial |
|
| Vfend Lyo-Injection | Active Comparator | Voriconazole, 200 mg/vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaway | Drug | Drug: Voriconazole. Pharmacokinetic study under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Time to reach peak concentration (Tmax) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Area under the plasma concentration-time curve from time zero to infinity (AUC 0-∞) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Elimination rate constant (入z) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and incidences | Any symptom, sign or significant abnormal laboratory finding whether observed or reported during the course of the study will be reported as an adverse event (AE) whether or not it has causative relationship with the drug | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
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Inclusion Criteria:
Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
Body weight within 80-120% of ideal body weight but not less than 45kg at the screening visit.
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 Period I dosing, which includes ASpartate aminoTransferase (AST), ALanine aminoTransferase (ALT), Gamma-Glutamyl-Transpeptidase (g-GT), alkaline phosphatase, total bilirubin, albumin, glucose, 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 Period I 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 Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein.
Female 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 this study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single Group Assignment
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| Terminal elimination half-life (t 1/2) | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |
| Ratio of AUC 0-t to AUC 0-∞ | The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%. | 0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours |