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A Study to Investigate Delayed-release Tablets

NCT02004301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-04-10

No results posted yet for this study

Summary

This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles.

We will be looking at:

1. The behaviour of the tablets (when, where and how quickly they break up)
2. The gastric emptying time of the tablets (when they leave the stomach)
3. The gastrointestinal transit of the tablets (how long they take to travel through the gut)
4. Blood levels of the drug (diclofenac)

Conditions

Interventions

DRUG

Radiolabelled T4 Tablet

DRUG

Radiolabelled T6 Tablet

Sponsors & Collaborators

  • Drug Delivery International Ltd

    collaborator INDUSTRY

  • BDD Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Howard NE Stevens, PhD · BDD Pharma Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 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

More Related Trials

Entities

Diseases

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 NCT02004301 on ClinicalTrials.gov