Pain Clinical Trial
Official title:
A Pharmacoscintigraphic Clinical Study to Investigate the in Vivo Behaviour of a Novel Delayed-release Formulation of Diclofenac in Comparison to the Voltaren® Enteric Coated Tablet Commercial Formulation in Healthy Volunteers
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)
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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