Taichung Veterans General Hospital
Taichung, Taiwan
NCT Number: NCT04552353
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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Notify Me20 year–45 year
All sexes
Interventional
Phase 4
Taichung, Taiwan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: Voriconazole. Pharmacokinetic study under fasting conditions
Other names: Vfend
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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
Yung Shin Pharm. Ind. Co., Ltd.
Industry
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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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.