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Study with Liposomal Amphotericin B in Healthy Volunteers to compare the blood concentration of the Test product with marketed product

An open label randomized two treatments two sequences two periods single dose crossover bioequivalence study of Liposomal Amphotericin B powder for solution for Infusion, 50 mg per vial of Bharat Serums and Vaccines Ltd, India and AmBisome 50mg per vial marketed by Gilead in healthy volunteers - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062043
Enrollment
58
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Amphonex Liposomal Amphotericin B for Injection: single dose of 3 mg per kg of Amphonex IV administration over 120 mins Control Intervention1: Ambisome 50 mg vial: single dose of 3 mg

Sponsors

Bharat Serums and Vaccines Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: BMI 18.5 to 29.9 kg per m2 and weight more than 50 kg Healthy volunteers Normal or clinical insignificant biochemical heamtological urine and serology parameters normal or clinical insignificant ECG Negative urine test for drugs of abuse alcohol breath analysis willing to use contraception willing to give informed consent and communicate effectively

Exclusion criteria

Exclusion criteria: history of surgical procedures in past history of clinical significant cardiac gastric renal endocrine neurological metabolic psychiatric hematological disorders history of chronic alcoholism chronic smoking drug of abuse hypersensitivity to liposomal amphotericin b or its excipients history of consumption of tobacco containing products

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters for Encapsulated Amphotericin B Primary PK parameters: Cmax, AUC0-t and AUC0-8 Pharmacokinetic parameters for Free Amphotericin B Primary PK parameters: Cmax, AUC0-t and AUC0-8Timepoint: pre dose and post dose many time points till day 7—

Secondary

MeasureTime frame
Pharmacokinetic parameters for Encapsulated Amphotericin B Secondary PK parameters: Tmax, T½, Kel, Cl, Vd and AUC_%Extrap_Obs Pharmacokinetic parameters for Free Amphotericin B Secondary PK parameters: Tmax, T½, Kel, Cl, Vd and AUC_%Extrap_ObsTimepoint: pre dose and post dose many time points till day 7—

Countries

India

Contacts

Public ContactDr Ramesh Jagannathan

Bharat serums and Vaccines LTd

ramesh.jagannathan@bsvgroup.com02245063456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026