NCT03636659

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

Multi-Center, Open-Label, Randomized, Two Treatment, Parallel, Single Period, Multiple-Dose, Steady State, Global Bioequivalence Study of Amphotericin B Liposome for Injection 50mg /Vial in Patients With Visceral Leishmaniasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Aurobindo Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Multi-Center, Open-Label, Randomized, Two treatment, Parallel, Single period, Multiple-Dose, Steady state, Global Bioequivalence study of Amphotericin B Liposome for Injection 50mg /vial of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) Liposome for Injection 50mg/vial of Astellas Pharma US, inc. in patients with Visceral Leishmaniasis under fed condition.Sufficient number of patients will be enrolled to have 140 evaluable patients. (90 to 100 patients from India and 40 to 50 patients from Bangladesh).

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Amphotericin B Liposome	Manufactured for: Auromedics Pharma LLC, USA
DRUG	AmBisome (Amphotericin B) Liposome	Marketed by: Astellas Pharma US, Inc. USA

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2018-08-17
• Last updated: 2019-08-26

Locations

3 sites across 2 countries: Bangladesh, India

Regulatory

• FDA-regulated drug study