Pharmacokinetics of Two Different Formulation of Voriconazole

Study Overview
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Brief Summary
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A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Formulation of Voriconazole 200 mg Tablets in Healthy Adult Subjects.

Official Title
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A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Formulation of Voriconazole 200mg Tablets in Healthy Adult Subjects

Conditions
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Fungus Infection

Intervention / Treatment
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* Drug: Vaway FC Tablets 200mg (Voriconazole)
* Drug: VFEND FC Tablets 200mg (Voriconazole)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult, aged between 20 to 45 years old. Physically and mentally healthy subjects as confirmed by an interview, medical history review, clinical examination, laboratory tests, chest x-ray and electrocardiogram (ECG). No clinically significant finding in clinical examination and laboratory tests within two months (60 days) prior to administration of study medication; Normal or clinically not significant at the discretion of the investigator chest X-ray and ECG results within six months (180 days) prior to administration of study medication. Body weight was above 50 kg for male and 45 kg for female. The body mass index should be between 18 and 27; body mass index equals [weight (kg)]/[height (m)]2. Laboratory determinations results were within normal range or considered not clinically significant by the investigator, including: Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), albumin, glucose, creatinine, uric acid, cholesterol, Triglycerides (TG), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, Blood Urea Nitrogen(BUN),Hepatitis B surface antigen (HBsAg), Anti-Hepatitis C virus (Anti-HCV) and Anti-Human Immunodeficiency Virus (Anti-HIV) test. Hematology test results were within normal range or considered not clinically significant by the investigator, including: hemoglobin, hematocrit, White Blood Cell (WBC) count, Red Blood Cell (RBC) count, platelet count and WBC count with differential. Urinalysis results were within normal range or considered not clinically significant by the investigator, including: glucose, protein, RBC, WBC, epith, casts and bacteria. Adequate contraceptive methods must be used during two weeks prior and two weeks after to the administration of study medication. Female subject who was: Using adequate contraception since last menstruation and no plan for conception during the study. Non-lactating. Had negative pregnancy test (urine) prior to the study. Informed consent form signed. Exclusion Criteria: A history of drug or alcohol abuse within 24 weeks prior to the study. History of drug allergy, allergic constitution, asthma or retinal disease. Myopia worse than 6.0 diopters. A clinically significant illness (such as hematological malignancy) within the past 4 weeks Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal disease within the past 4 weeks. Planned vaccination during the study. Participation of any clinical investigation during the last 60 days. Regular use of any medication during the last 4 weeks. Single use of any medication during the last 2 weeks. Blood donation of more than 250 mL within the past 12 weeks. Individuals were judged by the investigator to be undesirable as subjects.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaway FC Tablets<br>Vaway FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing | Drug: Vaway FC Tablets 200mg (Voriconazole)<br> <br> |
| Active Comparator: VFEND FC Tablets<br>VFEND FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing | Drug: VFEND FC Tablets 200mg (Voriconazole)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration (AUC) |  | Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr | 
| Peak Drug Concentration (Cmax) |  | Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr | 
| Time to reach Cmax (Tmax) |  | Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr | 
| Elimination half-life (T1/2) |  | Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr | 
| Area under the (first) moment plasma concentration-time curve (AUMC) |  | Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Within 8 weeks prior to the study, subjects were screened for their eligibility. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic