Pharmacokinetics of Two Different Formulation of Voriconazole

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.