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.
Overview
- Phase
- Phase 4
- Intervention
- Vaway
- Conditions
- Antimycotic for Systematic Use
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Ratio of AUC 0-t to AUC 0-∞
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
- •Ideal body weight (kg) = \[height (cm) - 80\] ´ 0.7 for male subjects
- •Ideal body weight (kg) = \[height (cm) - 70\] ´ 0.6 for female subjects
- •Acceptable medical history and physical examination including:
- •no particular clinically significant abnormalities in Electrocardiogram(ECG) results within six months prior to Period I dosing.
- •no particular clinical significance in general disease history within two months prior to Period I dosing.
- •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.
Exclusion Criteria
- •A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
- •A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator).
- •History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- •History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- •Known or suspected history of drug abuse within lifetime as judged by the investigator.
- •History of alcohol addiction or abuse within last five years as judged by the investigator.
- •History of allergic response(s) to voriconazole, any other drugs analogous to voriconazole, or any antibiotics.
- •Evidence of chronic or acute infectious diseases.
Arms & Interventions
Vaway Lyo-Injection
Voriconazole, 200 mg/vial
Intervention: Vaway
Vfend Lyo-Injection
Voriconazole, 200 mg/vial
Intervention: Vaway
Outcomes
Primary Outcomes
Ratio of AUC 0-t to AUC 0-∞
Time Frame: 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
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%.
Terminal elimination half-life (t 1/2)
Time Frame: 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
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%.
Area under the plasma concentration-time curve from time zero to infinity (AUC 0-∞)
Time Frame: 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
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%.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t)
Time Frame: 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
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%.
Elimination rate constant (入z)
Time Frame: 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
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%.
Peak concentration (Cmax)
Time Frame: 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
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%.
Time to reach peak concentration (Tmax)
Time Frame: 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
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%.
Secondary Outcomes
- Adverse events and incidences(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)