Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed
and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized
albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen
injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will
enable the use of a liquid product in a ready-to-use single dose auto-injector. To support
the development of the liquid auto-injector product, this healthy volunteer bioequivalence
study will be conducted to compare the liquid drug product to the currently available
lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,
2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics
and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial
lyophilized drug product.