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

NCT02714842 Phase 1 COMPLETED

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)

Details

Lead sponsor	BDD Pharma Ltd
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2016-03
Completion	2016-05

Conditions

• Pain

Interventions

• Radiolabelled Diclofenac Tablet A
• Radiolabelled Diclofenac tablet B
• Radiolabelled Diclofenac tablet C
• Diclofenac

Primary outcomes

• Gastrointestinal transit parameters - gastric emptying time, small intestinal transit time, and colon arrival time of radiolabel where applicable. — 16 hours
  Composite outcome

Countries

United Kingdom