NCT05496725

Evaluate Bioequivalence of Micafungin (50mg/Vial)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Micafungin	Pharmacokinetic study under fasting conditions

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-05-30
• Completion: 2022-07-28
• First posted: 2022-08-11
• Last updated: 2022-08-11

Locations

1 site across 1 country: Taiwan