Overview

Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

Status:
Completed
Trial end date:
2019-04-05
Target enrollment:
Participant gender:
Summary
The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition
Phase:
Phase 1
Details
Lead Sponsor:
Aurobindo Pharma Ltd
Collaborator:
Axis Clinicals Limited
Treatments:
Amphotericin B
Liposomal amphotericin B