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Bioequivalence study of Liposomal Amphotericin B 50 mg/vial of Bharat Serums and Vaccines Ltd.

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/vial of Bharat Serums and Vaccines Ltd, India and AmBisome® 50mg/vial marketed by Gilead in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052602
Enrollment
14
Registered
2023-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

None listed

Interventions

Intervention1: Liposomal Amphotericin B: Powder for solution manufactured by Bharat Serums and Vaccines ltd. 50 mg/vial dose/route of administration -single dose 3mg/kg IV infusion over 2 hours Contro

Sponsors

Bharat Serums and Vaccines Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male volunteers Subject who can give written informed consent and communicate effectively

Exclusion criteria

Exclusion criteria: History of any major surgical procedure History of any clinically significant medical conditions. History of chronic alcoholism/ chronic smoking/ drug of abuse. Subjects with known hypersensitivity to Liposomal Amphotericin B or any of the excipients.

Design outcomes

Primary

MeasureTime frame
To evaluate the pharmacokinetic profile of Test formulation in comparison to the Reference productTimepoint: PK samples will be collected predose, post dose every hour till 8 hours then every 2 hours till 14 hours. then 4 hourly till 24 hours, then daily till day 7—

Secondary

MeasureTime frame
Safety and tolerability of liposomal amphotericin bTimepoint: Post dose AEs will be captured till the end of study—

Countries

India

Contacts

Public ContactDr Ramesh Jagannathan

Bharat Serums and Vaccines Ltd.

Ramesh.Jagannathan@bsvgroup.com02245043456

Outcome results

None listed

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