Evaluate Bioequivalence of Micafungin (50mg/Vial)

NCT05496725 | Completed Phase 4

• 1 other identifier: YSP-RNH3001-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Invasive Candidiasis

Outcome Measures

Primary Outcomes (4)

• Peak plasma concentration (Cmax)

  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)

  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-∞)

  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-∞)

  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.

  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

Study Arms (2)

Micafungin (Product name:Myfungin)

EXPERIMENTAL

Single dose micafungin 50mg

Drug: Micafungin

Micafungin (Product name:Mycamine)

ACTIVE COMPARATOR

Single dose micafungin 50mg

Drug: Micafungin

Interventions

Micafungin DRUG

Pharmacokinetic study under fasting conditions

Micafungin (Product name:Mycamine); Micafungin (Product name:Myfungin)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Female subjects who are currently breastfeeding.
• Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
• Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to Period I dosing.
• Use of any investigational drug within four weeks prior to Period I dosing.
• Use of any COVID-19 vaccine within seven days prior to Period I dosing.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 11, 2022
• Study Start: January 6, 2022
• Primary Completion: May 30, 2022
• Study Completion: July 28, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)