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Pharmacokinetics of Two Different Formulation of Voriconazole

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ClinicalTrials.gov Identifier: NCT02912156
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Taichung Veterans General Hospital
Information provided by (Responsible Party):
Yung Shin Pharm. Ind. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Fungus Infection Drug: Vaway FC Tablets 200mg (Voriconazole) Drug: VFEND FC Tablets 200mg (Voriconazole) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Formulation of Voriconazole 200mg Tablets in Healthy Adult Subjects
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaway FC Tablets
Vaway FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing
Drug: Vaway FC Tablets 200mg (Voriconazole)
Active Comparator: VFEND FC Tablets
VFEND FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing
Drug: VFEND FC Tablets 200mg (Voriconazole)



Primary Outcome Measures :
  1. Area under the plasma concentration (AUC) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr ]
  2. Peak Drug Concentration (Cmax) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr ]
  3. Time to reach Cmax (Tmax) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr ]
  4. Elimination half-life (T1/2) [ Time Frame: Plasma sample: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hr ]
  5. Area under the (first) moment plasma concentration-time curve (AUMC) [ Time Frame: 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 :
  1. Adverse events [ Time Frame: Within 8 weeks prior to the study, subjects were screened for their eligibility. ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult, aged between 20 to 45 years old.
  2. 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.
  3. Body weight was above 50 kg for male and 45 kg for female.
  4. The body mass index should be between 18 and 27; body mass index equals [weight (kg)]/[height (m)]2.
  5. 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.
  6. 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.
  7. Urinalysis results were within normal range or considered not clinically significant by the investigator, including: glucose, protein, RBC, WBC, epith, casts and bacteria.
  8. Adequate contraceptive methods must be used during two weeks prior and two weeks after to the administration of study medication.
  9. 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.
  10. Informed consent form signed.

Exclusion Criteria:

  1. A history of drug or alcohol abuse within 24 weeks prior to the study.
  2. History of drug allergy, allergic constitution, asthma or retinal disease.
  3. Myopia worse than 6.0 diopters.
  4. A clinically significant illness (such as hematological malignancy) within the past 4 weeks
  5. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal disease within the past 4 weeks.
  6. Planned vaccination during the study.
  7. Participation of any clinical investigation during the last 60 days.
  8. Regular use of any medication during the last 4 weeks.
  9. Single use of any medication during the last 2 weeks.
  10. Blood donation of more than 250 mL within the past 12 weeks.
  11. Individuals were judged by the investigator to be undesirable as subjects.

Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02912156     History of Changes
Other Study ID Numbers: YSP-RIH3001-01
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Yung Shin Pharm. Ind. Co., Ltd.:
Pharmacokinetic

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors