Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects
Status:
Completed
Trial end date:
2020-11-09
Target enrollment:
Participant gender:
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]).
Phase:
Phase 1
Details
Lead Sponsor:
Aphaia Pharma US LLC
Collaborators:
ACC GmbH Analytical Clinical Concepts Galephar Pharmaceutical Research (PR), Inc. NovaClin Medical Research Center S.R.L SC Bioclinica SA