Open-Label, Randomized, Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
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. Also
collection of physiologic data (such as pressure, temperature and GI transit time) from GI
tract through an electronic pill taken by mouth called SmartPill.
Expanding current knowledge of drug dissolution in vivo will help to establish
physiologically relevant in vitro models predictive of drug dissolution.