Pharmacokinetics of Two Different Formulation of Voriconazole

Fungus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912156
• Other study ID #: YSP-RIH3001-01
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2016
• Last updated: September 22, 2016
• Start date: June 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Yung Shin Pharm. Ind. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 (?-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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fungus Infection
• Mycoses

Intervention

Drug:
• Vaway FC Tablets 200mg (Voriconazole)

• VFEND FC Tablets 200mg (Voriconazole)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yung Shin Pharm. Ind. Co., Ltd.	Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Adverse events		Within 8 weeks prior to the study, subjects were screened for their eligibility.	Yes