Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects

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.

Conditions

• Metabolic Syndrome
• Obesity

Interventions

DRUG

coated beads glucose (8 g) and caffeine anhydrous

After an overnight fasting of about 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 on Day 1.

DRUG

coated beads glucose (8 g) and caffeine anhydrous

After an overnight fasting of about 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 on Day 1.

DRUG

coated beads glucose (8 g) and caffeine anhydrous

After an overnight fasting of about 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 on Day 1.

DRUG

coated beads glucose (8 g)

After an overnight fasting of about 10 hours the subjects were administered glucose (8 g) starting at 8:00 (time 0; administration time was staggered beginning at 8:00 for the first group of subjects) in sitting position on Day 1.

DRUG

uncoated beads glucose (8 g) and caffeine anhydrous

After an overnight fasting of about 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 on Day 1.

Sponsors & Collaborators

• ACC GmbH Analytical Clinical Concepts, Germany

  collaborator UNKNOWN

• Nova-Clin Medical Research Center S.R.L., Romania

  collaborator UNKNOWN

• BioClinica, Inc.

  collaborator INDUSTRY

• Galephar Pharmaceutical Research (PR), Inc, Puerto Rico

  collaborator UNKNOWN

• Aphaia Pharma US LLC

  lead INDUSTRY

Principal Investigators

• Carmen Vizman, Doctor · Aphaia Pharma AG

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

2019-10-25

Primary Completion

2019-12-03

Completion

2019-12-03

Countries

• Romania

Study Locations