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

Summary

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 \[T2\]).

Timeline

Start

2020-09-16

Primary completion

2020-11-09

Completion

2020-11-09

Drugs

Indications