Delayed Release Diclofenac Sodium Formulation vs Voltaren®
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
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)