Pharmacokinetics of Two Different Formulation of Voriconazole

NCT02912156 | Completed Phase 4

• 1 other identifier: YSP-RIH3001-01
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fungus Infection

Keywords

Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Adverse events

  Within 8 weeks prior to the study, subjects were screened for their eligibility.

Study Arms (2)

Vaway FC Tablets

EXPERIMENTAL

Vaway FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing

Drug: Vaway FC Tablets 200mg (Voriconazole)

VFEND FC Tablets

ACTIVE COMPARATOR

VFEND FC Tablets 200mg (Voriconazole) Dosing Regimen: Single dosing

Drug: VFEND FC Tablets 200mg (Voriconazole)

Interventions

Vaway FC Tablets 200mg (Voriconazole) DRUG

Vaway FC Tablets

VFEND FC Tablets 200mg (Voriconazole) DRUG

VFEND FC Tablets

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead
• Taichung Veterans General Hospital: collaborator

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09