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 \[T2\]).

Conditions

• Obese

Interventions

DRUG

Glucose 8 g coated beads (47% w/w)

After an overnight fasting of about 10 hours, the subjects were administered 8 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.

DRUG

Glucose 12 g coated beads (47% w/w)

After an overnight fasting of about 10 hours, the subjects were administered 12 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.

DRUG

Glucose 16 g coated beads (47% w/w)

After an overnight fasting of about 10 hours, the subjects were administered 16 g glucose of the coated Glucose beads formulation starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.

DRUG

Glucose 12 g uncoated beads

After an overnight fasting of about 10 hours, the subjects were administered the uncoated Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.

DRUG

Glucose 12 g coated beads (60% w/w)

After an overnight fasting of about 10 hours, the subjects were administered the coated Glucose beads formulation (60 % w/w glucose/bead; 12 g glucose) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position.

DRUG

Glucose 12 g coated beads (47% w/w)

After an overnight fasting of at least 10 hours, the subjects were administered the new developed Glucose beads formulation containing 12 g glucose starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position. Treatment duration: Day 1 - Day 4

Sponsors & Collaborators

• NovaClin Medical Research Center S.R.L

  collaborator UNKNOWN

• ACC GmbH Analytical Clinical Concepts

  collaborator UNKNOWN

• SC Bioclinica SA

  collaborator UNKNOWN

• Galephar Pharmaceutical Research (PR), Inc.

  collaborator UNKNOWN

• Aphaia Pharma US LLC

  lead INDUSTRY

Principal Investigators

• Carmen Vizman · NovaClin Medical Research Center S.R.L

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-16

Primary Completion

2020-11-09

Completion

2020-11-09

Countries

• Romania

Study Locations