Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects
Status:
Completed
Trial end date:
2019-12-03
Target enrollment:
Participant gender:
Summary
This single-dose, randomized, open label, five-treatment, five-period, five-sequence
crossover study was performed to assess pharmacodynamics (PD) and pharmacokinetics (PK) of
three new developed coated Glucose beads formulations (containing glucose (8 g) and
caffeine), one coated Glucose beads formulation (containing glucose (8 g)) and one uncoated
Glucose beads formulation (containing Glucose (8 g) and caffeine) after single-dose
administration (fasting conditions) in 20 obese healthy subjects. After an overnight fasting
of at least 10 hours the subjects were administered either glucose (8 g) or glucose (8 g) and
caffeine starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for
the first group of subjects) in sitting position. At least 3 days wash-out period was kept
between each treatment periods.
Phase:
Phase 1
Details
Lead Sponsor:
Aphaia Pharma US LLC
Collaborators:
ACC GmbH Analytical Clinical Concepts, Germany BioClinica, Inc. Galephar Pharmaceutical Research (PR), Inc, Puerto Rico Nova-Clin Medical Research Center S.R.L., Romania