NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

November 9, 2020

Study Completion Date

November 9, 2020

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

Trial Locations (1)

300696

NovaClin Medical Research Center S.R.L, Timișoara