Evaluate Bioequivalence of Voriconazole(200mg/Vial) .

NCT ID: NCT04552353

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-13
• Study Completion Date: 2020-06-21

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaway Lyo-Injection

Voriconazole, 200 mg/vial

Group Type: EXPERIMENTAL

Vaway

Intervention Type: DRUG

Drug: Voriconazole. Pharmacokinetic study under fasting conditions

Vfend Lyo-Injection

Voriconazole, 200 mg/vial

Group Type: ACTIVE_COMPARATOR

Vaway

Intervention Type: DRUG

Drug: Voriconazole. Pharmacokinetic study under fasting conditions

Interventions

Vaway

Drug: Voriconazole. Pharmacokinetic study under fasting conditions

Intervention Type: DRUG

Other Intervention Names

Vfend

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yung Shin Pharm. Ind. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

YSP-RKH3003-01

Identifier Type: -

Identifier Source: org_study_id