Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
Condition: Aspergillus Infections; Candida Infections; Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Candidiasis; Aspergillosis
Intervention: Vorico Injection 200mg(Voriconazole); Vfend®(Voriconazole) IV 200mg
Intervention description: Vorico Injection 200mg(Voriconazole) to administered intravenously once; Vfend®(Voriconazole) IV 200mg to administered intravenously once
Intervention MeSH terms: Voriconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection
      200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in
      Healthy Volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          1. A healthy person whose age is in between 19 to 55 during the screening tests

          2. Whose weight is more than 55 kg, BMI is over 18.5 and under 30.0 during the screening
             test. (BMI (kg/m2) = weight (kg) / {height (m)}2)

          3. Who is completely informed and understand about this clinical trial, voluntarily
             participating it, and signed to follow the given instructions

          4. Who is proven to fit into the clinical trial following by physical examination, ECG
             (electrocardiogram), clinical laboratory test, medical examination

          5. Who agreed to do birth control during testing

               -  A male who did not have vasectomy has to follow the clinically proven
                  contraceptive methods* listed under, and who agreed not to donate sperm during
                  the test

                  * Clinically proven contraceptive method: intrauterine device (ex. Lippes Loop,
                  Minera), chemical contraceptive (spermicides) for use with physical contraceptive
                  method (males or females), contraceptive implants (ex. Implanon), tubal ligation
                  or laparoscopy (common methods of tubal ligation)

               -  A woman of childbearing age who agreed on constant use of a medically disproven
                  Dual Protection method** and spermicides except hormonal contraceptive, and who
                  also agreed not to breastfeed.

                    -  A Dual Protection method: use of condoms, the Intrauterine Contraceptive
                       Device, the diaphragm, the cervical cap, in the case where a sexual partner
                       had vasectomy over 3 months ago (from the date of initial screening) or a
                       sexual partner had been medically diagnosed sterile.

        Exclusion Criteria:

          1. A person who has a history of clinically significant cardiovascular, respiratory,
             liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor
             diseases, mental illness.

          2. Who has a history of hypersensitivity reactions to antifungal drugs including
             voriconazole or similar series or other excipient ingredients (aspirin, antibiotics,
             etc.)

          3. Who has genetics issues on galactose intolerance, Lapp lactose deficiency, or
             glucose-galactose malabsorption

          4. Who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or
             chronic pancreatitis, etc.) or gastrointestinal surgery (other than simple
             appendectomy and herniotomy)

          5. A person whose electrocardiogram value includes QTc > 440 msec, PR < 110 msec or PR >
             200 msec, QRS < 60 msec or QRS > 110 msec after screening, or who show clinically
             significant opinion.

          6. Who falls under the following results

               1. AST, ALT are exceeded over 1.5x the upper limit of the normal range

               2. Total bilirubin is exceeded over 1.5x the upper limit of the normal range

          7. Who shows the vital sign values of more than 140 mmHg or less than 90 mmHg in systolic
             pressure or more than 100 mmHg or less than 60 mmHg in diastolic blood pressure

          8. Who has history of drug abuses or shows a positive result in the urinary drug screen

          9. Who took any prescribed drugs, medicinal plants within the 2 weeks before the first
             day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week
             (but, if other conditions are met, they can still participate in the clinical test
             through the researcher's judgment)

         10. Who took other investigational drugs or bioequivalence drugs within 3 months before
             the first day of dosing

         11. Who participated in whole blood donation within 2 months before the first of dosing,
             or platelet donations within 1 months. Who received blood a month before the first day
             of dosing

         12. Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or
             cannot stop drinking alcohol during the clinical test.

         13. Who smokes more than 10 cigarettes per day, or who cannot quit smoking when
             hospitalized

         14. Who absorb caffeinated drinks (coffee, tea (black or green tea), soda, coffee flavored
             milk, energy drinks, etc.) or cannot stop absorbing them 24 hours before
             hospitalization until discharging

         15. Who takes drug metabolism drug like barbital drugs which inhibit or activate the
             metabolism or drugs, or who takes one of the following drugs: St. John's Wort,
             rifabutin, rifampicin, carbamazepine, phenobarbital, high-dose of ritonavir,
             terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, ergot, alkaloid
             (ergotamine, dihydroergotamine), efavirenz

         16. Who was having foods (especially grapefruit or products contain grapefruit) that can
             influence the drug absorption, distribution, metabolism, and excretion within 7 days
             from the first day of dosage

         17. A woman who is pregnant, shows positive result in serum/urine test, or who is
             breastfeeding