Antimycotic for Systematic Use Clinical Trial
Official 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.
| Verified date | September 2020 |
| Source | Yung Shin Pharm. Ind. Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | June 21, 2020 |
| Est. primary completion date | June 21, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 45 Years |
| Eligibility |
Inclusion Criteria: 1. Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit. 2. 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 3. 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. 4. 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). 5. 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. 6. 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. 7. Female of childbearing potential practicing an acceptable method of birth control for the duration of the study. 8. Have signed the written informed consent to participate in this study. Exclusion Criteria: 1. 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). 2. A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator). 3. 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. 4. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant. 5. Known or suspected history of drug abuse within lifetime as judged by the investigator. 6. History of alcohol addiction or abuse within last five years as judged by the investigator. 7. History of allergic response(s) to voriconazole, any other drugs analogous to voriconazole, or any antibiotics. 8. Evidence of chronic or acute infectious diseases. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taichung Veterans General Hospital | Taichung |
| Lead Sponsor | Collaborator |
|---|---|
| Yung Shin Pharm. Ind. Co., Ltd. |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Area under the plasma concentration-time curve from time zero to infinity (AUC 0-8) | 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 | |
| Primary | Elimination rate constant (?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 | |
| Primary | 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 | |
| Primary | Ratio of AUC 0-t to AUC 0-8 | 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 | Adverse events and incidences | 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 | 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 |