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Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects

Aphaia Pharma US LLC · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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obese
The goal of this clinical study was to assess pharmacodynamics (PD) and pharmacokinetics (PK) of different Glucose beads formulations in obese healthy subjects under fasting condition. The study was designed in 2 parts. Part 1 (single-dose) of the study was randomized, open label, five-treatment, five-period, five-sequence, crossover and single-centric. Treatment arms were three dosages of a coated Glucose beads formulation (47% w/w glucose/bead; 8 g \[T1\], 12 g \[T2\] and 16 g glucose \[T3\]), one uncoated Glucose beads formulation (47% w/w glucose/bead; 12 g glucose \[T4\]) and one coated Glucose beads formulation (60% w/w glucose/bead;12 g glucose \[T5\]). Part 2 (multiple-dose) of the study was open label, one-treatment, one-period and single-centric. Treatment arm was coated Glucose beads formulation (12 g glucose \[T2\]).
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