NCT02025348

Explore the Performance of IntelliCap.

A Randomised, Open-label, 4-way Crossover Study in Healthy Subjects to Explore the Performance of IntelliCap® by Comparing Pharmacokinetic Profiles of a Probe Drug.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers. The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.

Conditions

• Plasma Concentration
• Pharmacokinetic Profile

Interventions

Type	Name	Description
DRUG	IntelliCap	Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-01-01
• Last updated: 2016-01-27

Locations

1 site across 1 country: United Kingdom