Delayed Release Diclofenac Sodium Formulation vs Voltaren®

Summary

This is a single-centre, open-label, randomised, three-arm crossover study with a fourth fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the study. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption profiles. The investigators 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)

Timeline

Start

2016-03

Primary completion

2016-05

Completion

2016-05

Drugs

Indications

No indication recorded.