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)
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Bio-Imaging Centre, Basement Medical Block, Within Glasgow Royal Infirmary, 84 Castle Street
Glasgow, United Kingdom
Scintigraphic analysis of time and site of onset and complete release of radiolabel
Time frame: 15 hours
Pharmacokinetic (PK) absorption profiles and parameters of diclofenac
Time frame: 15 hours
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