A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 16, 2021

Primary Completion Date

November 14, 2021

Study Completion Date

December 16, 2021

Conditions
Natural Blood and Blood Product Toxicity
Interventions
BIOLOGICAL

Erythropoietin alpha

To analyze bio-similarity of GBPD002 with Eprex®, the Globe Biotech Ltd performed quite a few experiments to determine total analytical study of GBPD002. They performed peptide mapping to determine amino acid composition of GBPD002 and found similar result with erythropoietin alpha. The molecular weight was determined through SDS-PAGE analysis of GBPD002 and was compared with Eprex. The western blot analysis was performed to determine immune chemical characterization. Characterization of different isoforms was conducted through 2D gel electrophoresis.

Trial Locations (2)

1208

Globe Biotech Limited, Dhaka

1209

Farabi General Hospital, Dhaka

Sponsors
All Listed Sponsors
lead

Globe Biotech Limited

INDUSTRY