Clinical trial NCT02912156: Pharmacokinetics of Two Different Formulation of Voriconazole
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fungus Infection
Keywords: Pharmacokinetic
Lead sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taichung Veterans General Hospital
First posted: 2016-09-23
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

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