University of Michigan
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.
This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects which are necessary for mechanistic absorption model development. Each subject will be asked to complete a single dosing phase. The dosing phase will include collection of fluids from stomach and gastrointestinal (GI) tract through intubation (putting a GI tube from mouth into stomach and intestines), blood, urine and feces, and measure glipizide concentrations. The objectives of this study are, as follows: Objective #1: To characterize the plasma, gastrointestinal fluid, urine, and…
Inclusion Criteria: 1. Male or female adults age 18 to 55 years with BMI ranging from 18.5 to 35 kg/m2 inclusive 2. Ability to independently provide an informed consent 3. Demonstrate the ability to swallow a multivitamin pill that mimics a SmartPill capsule 4. Negative serum pregnancy test (for women of child-bearing potential) Exclusion Criteria: 1. Unable to independently provide an informed consent for themselves or mentally incapacitated. 2. Physical disability (including blindness or deafness) that requires special arrangements. 3. Significant clinical illness, including cardiovascula…
Participants are randomized to take one tablet of this study drug by mouth.
Participants are randomized to take one tablet of this study drug by mouth.
Participants will take one tablet of this study drug by mouth.
Participants will take 1 mg of this study drug dissolved in 40 ml glucose solution by mouth.
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