A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Micafungin (50 mg/Vial) After Intravenous Infusion of 50 mg Micafungin in Healthy Volunteers Under Fasting Conditions
Overview
- Phase
- Phase 4
- Intervention
- Micafungin
- Conditions
- Invasive Candidiasis
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Peak plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of micafungin (50 mg/vial) after intravenous infusion of 50 mg micafungin in healthy volunteers under fasting conditions
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
- •Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
- •Acceptable medical history and physical examination including:
- •no particular clinically significant abnormalities in 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 AST (SGOT), ALT (SGPT), γ-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 the study.
Exclusion Criteria
- •A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
- •A clinically significant illness or surgery within four weeks prior to Period I dosing.
- •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.
- •History of alcohol addiction or abuse within last five years or use of more than 7 units of alcohol per week within two weeks prior to dosing. (1 unit of alcohol = 10 g of alcohol or about 350 mL of beer or about 83 mL of red wine or about 30 mL of beverage containing 40% (v/v) alcohol).
- •History of allergic response(s) to palonosetron or any other related drugs.
- •Evidence of chronic or acute infectious diseases.
- •Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- •Female subjects demonstrating a positive pregnancy screen prior to the study.
Arms & Interventions
Micafungin (Product name:Myfungin)
Single dose micafungin 50mg
Intervention: Micafungin
Micafungin (Product name:Mycamine)
Single dose micafungin 50mg
Intervention: Micafungin
Outcomes
Primary Outcomes
Peak plasma concentration (Cmax)
Time Frame: 0 (pre-dose), 20 and 40 minutes, and 5, 15, 30 minutes, 1, 2, 3, 5, 7, 11, 23, 35,47 and 59 hours post dose
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t)
Time Frame: 0 (pre-dose), 20 and 40 minutes, and 5, 15, 30 minutes, 1, 2, 3, 5, 7, 11, 23, 35,47 and 59 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
Time Frame: 0 (pre-dose), 20 and 40 minutes, and 5, 15, 30 minutes, 1, 2, 3, 5, 7, 11, 23, 35,47 and 59 hours post dose
Ratio of area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t) to Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
Time Frame: 0 (pre-dose), 20 and 40 minutes, and 5, 15, 30 minutes, 1, 2, 3, 5, 7, 11, 23, 35,47 and 59 hours post dose
Calculate the ratio between Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-t) and Area under the concentration-time curve from time zero to infinity (AUC 0-∞). It require no less than 0.8.