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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 25, 2019

Primary Completion Date

December 3, 2019

Study Completion Date

December 3, 2019

Conditions
Metabolic SyndromeObesity
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.

Trial Locations (1)

300696

Nova-Clin Medical Research Center S.R.L.,, Timișoara

Sponsors
All Listed Sponsors
collaborator

ACC GmbH Analytical Clinical Concepts, Germany

UNKNOWN

collaborator

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

UNKNOWN

collaborator

BioClinica, Inc.

INDUSTRY

collaborator

Galephar Pharmaceutical Research (PR), Inc, Puerto Rico

UNKNOWN

lead

Aphaia Pharma US LLC

INDUSTRY

NCT05713773 - Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects | Biotech Hunter | Biotech Hunter