Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers

Conditions

• Human Gastrointestinal Physiology Data

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Glucotrol XL 5Mg Extended-Release Tablet — DRUG
  Participants are randomized to take one tablet of this study drug by mouth.
• Glipizide ER 5 MG 24 HR Extended Release Oral Tablet — DRUG
  Participants are randomized to take one tablet of this study drug by mouth.
• Rifaximin 200Mg Tab — DRUG
  Participants will take one tablet of this study drug by mouth.
• 13C6-Glipizide — DRUG
  Participants will take 1 mg of this study drug dissolved in 40 ml glucose solution by mouth.

Study Details

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study is to evaluate the in vivo drug dissolution and systemic absorption of modified release formulations of the BCS Class II drug Glipizide by direct sampling of stomach and small intestinal luminal content, blood, urine and feces. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Key Dates

Start date

Mar 15, 2022

Status verified

Mar 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: G.I Intubation
  Single dose of Glipizide (5 mg modified-release tablet) and Rifaximin (200 mg tablet) administered with 200 mL of 20% glucose solution in water + 1 mg of the stable isotope Glipizide (13C6-Glipizide) with 40 ml of 14% glucose solution in water. A 'Stable isotope' means a heavier version of the drug that is not radioactive.

Primary Outcome Measure

Average Area Under the Plasma Concentration-time Curve to infinite time (AUCinfinity) of Glipizide After a Single Dose of Glipizide with Gastrointestinal Intubation and between Two Modified Release Glipizide formulations [ Time Frame: From time 0 to 78 hours ]

Central Contacts

• Cathrin Ring
  3136221119
  [email protected]

Locations (1)

Find similar trials in Ann Arbor, MI