A Randomized, Double‐Blind, Single‐Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants

Le résumé fourni par la source

Abstract Albiglutide, developed for treatment of type 2 diabetes mellitus, is provided in a dual‐chamber cartridge (DCC) single‐dose pen‐injector containing lyophilized drug that must be reconstituted with diluent prior to use. A liquid formulation of albiglutide has been developed that does not require mixing. In this 2‐period, randomized, crossover, double‐blind, phase I study (NCT02660736) in 59 healthy volunteers, pharmacokinetic parameters were determined and the bioequivalence of the 2 formulations was assessed. Participants received injections from each type of pen‐injector, one containing albiglutide 50 mg and one containing placebo, followed by an 8‐week washout period between regimens: albiglutide 50‐mg liquid formulation from an auto‐injector and lyophilized placebo from a DCC pen‐injector (Regimen A), or placebo liquid from an auto‐injector and lyophilized albiglutide 50 mg from a DCC pen‐injector (Regimen B). Geometric mean total exposures (area under the drug concentration–time curve [AUC](0‐t) [1345.4 vs 1426.9 (μg · h/mL)], AUC(0‐∞) [1376.2 vs 1454.6 (μg · h/mL)], and maximum concentration of drug in blood plasma [4968.5 vs 5314.7 ng/mL]) were comparable between Regimens A and B. Ratios of geometric least square means (90% confidence interval) were 95.3% (89.49‐101.52) for AUC(0‐∞), 95.1% (89.12‐101.49) for AUC(0‐t), and 93.2% (86.76‐100.17) for maximum concentration of drug in blood plasma, falling within the 90% confidence interval of 0.80 to 1.25 for bioequivalence. No new safety concerns were observed.

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