Pain Clinical Trial - A Study to Investigate Delayed-release Tablets

Status Completed

Clinical Trial 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)

Clinical Trial Description

The tablets being tested will contain the drug, diclofenac potassium. Diclofenac potassium is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic, reducing pain in certain conditions such as rheumatoid arthritis, gout and post-operative pain.

The 2 treatments are as follows:

Tablet T4: Radiolabelled delayed release diclofenac potassium tablet with time delay of 4 h

Tablet T6: Radiolabelled delayed release diclofenac potassium tablet with time delay of 6 h

In this study we will be using a type of radioactive material (known as technetium-99m) which is routinely used in investigations of this type. A small amount of technetium-99m will be put into each tablet.

Primary Objective A)To assess the site and time of onset and complete release of radiolabel from two delayed-release diclofenac potassium formulations

Secondary Objectives B)To determine gastrointestinal transit parameters of two delayed-release diclofenac potassium formulations C)To determine the plasma concentrations of diclofenac at each PK sampling point post-administration of two delayed-release diclofenac potassium formulations D)To assess and compare between the two delayed-release diclofenac potassium formulations, as a minimum, the following PK parameters: tlag, tmax, Cmax and AUC0-15h ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Pain

Clinical Trial Details

NCT number	NCT02004301
Study type	Interventional
Source	Bio-Images Research Ltd
Contact
Status	Completed
Phase	Phase 1
Start date	January 2014
Completion date	March 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.