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Explore the Performance of IntelliCap.

NCT02025348 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-01-27

No results posted yet for this study

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

DRUG

IntelliCap

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

Sponsors & Collaborators

Principal Investigators

  • Salvatore Febbraro, MD PhD · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025348 on ClinicalTrials.gov