Pharmacokinetics of Two Different Formulation of Voriconazole

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

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

Study Overview

• Status: Completed
• Conditions: Fungus Infection
• Intervention / Treatment: Drug: Vaway FC Tablets 200mg (Voriconazole); Drug: VFEND FC Tablets 200mg (Voriconazole)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
• Collaborators: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetic
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: YSP-RIH3001-01