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Completed

NCT Number: NCT04552353

Evaluate Bioequivalence of Voriconazole(200mg/Vial) .

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vaway

Drug

Drug: Voriconazole. Pharmacokinetic study under fasting conditions

Other names: Vfend

Primary outcomes

  1. Peak concentration (Cmax)

    Time frame: 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

    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%.

  2. Time to reach peak concentration (Tmax)

    Time frame: 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

    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%.

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

    Time frame: 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

    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%.

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

    Time frame: 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

    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%.

  5. Elimination rate constant (入z)

    Time frame: 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

    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%.

  6. Terminal elimination half-life (t 1/2)

    Time frame: 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

    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%.

  7. Ratio of AUC 0-t to AUC 0-∞

    Time frame: 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

    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%.

Secondary outcomes

  1. Adverse events and incidences

    Time frame: 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

    Any symptom, sign or significant abnormal laboratory finding whether observed or reported during the course of the study will be reported as an adverse event (AE) whether or not it has causative relationship with the drug

Sponsors and collaborators

Lead sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.