Evaluate Bioequivalence of Voriconazole(200mg/Vial) .

NCT04552353 | Completed Phase 4

• 1 other identifier: YSP-RKH3003-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole in Healthy Volunteers Under Fasting Conditions.

Conditions

Antimycotic for Systematic Use

Outcome Measures

Primary Outcomes (7)

• Peak concentration (Cmax)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Time to reach peak concentration (Tmax)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Area under the plasma concentration-time curve from time zero to infinity (AUC 0-∞)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Elimination rate constant (入z)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Terminal elimination half-life (t 1/2)

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

• Ratio of AUC 0-t to AUC 0-∞

  The 90% confidence intervals of the geometric mean ratio (test/reference) for all parameters of voriconazole should fall within the range of 80.00% and 125.00%.

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

Secondary Outcomes (1)

• Adverse events and incidences

  0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12, 24, and 36 hours

Study Arms (2)

Vaway Lyo-Injection

EXPERIMENTAL

Voriconazole, 200 mg/vial

Drug: Vaway

Vfend Lyo-Injection

ACTIVE COMPARATOR

Voriconazole, 200 mg/vial

Drug: Vaway

Interventions

Vaway DRUG

Drug: Voriconazole. Pharmacokinetic study under fasting conditions

Also known as: Vfend

Vaway Lyo-Injection; Vfend Lyo-Injection

Eligibility Criteria

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

You may qualify if:

• Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
• Body weight within 80-120% of ideal body weight but not less than 45kg at the screening visit.
• Ideal body weight (kg) = \[height (cm) - 80\] ´ 0.7 for male subjects
• Ideal body weight (kg) = \[height (cm) - 70\] ´ 0.6 for female subjects
• Acceptable medical history and physical examination including:
• no particular clinically significant abnormalities in Electrocardiogram(ECG) results within six months prior to Period I dosing.
• no particular clinical significance in general disease history within two months prior to Period I dosing.
• Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes ASpartate aminoTransferase (AST), ALanine aminoTransferase (ALT), Gamma-Glutamyl-Transpeptidase (g-GT), alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, and triglyceride (TG).
• Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
• Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein.
• Female of childbearing potential practicing an acceptable method of birth control for the duration of the study.
• Have signed the written informed consent to participate in this study.

You may not qualify if:

• A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
• A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator).
• History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
• History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
• Known or suspected history of drug abuse within lifetime as judged by the investigator.
• History of alcohol addiction or abuse within last five years as judged by the investigator.
• History of allergic response(s) to voriconazole, any other drugs analogous to voriconazole, or any antibiotics.
• Evidence of chronic or acute infectious diseases.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

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

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: June 13, 2020
• Primary Completion: June 21, 2020
• Study Completion: June 21, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

TW (1)