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Delayed Release Diclofenac Sodium Formulation vs Voltaren®

NCT02714842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-09-28

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Radiolabelled Diclofenac Tablet A

Delayed release diclofenac sodium tablet (50 mg)

DRUG

Radiolabelled Diclofenac tablet B

Delayed release diclofenac sodium tablet (50 mg)

DRUG

Radiolabelled Diclofenac tablet C

Delayed release diclofenac sodium tablet (25 mg)

DRUG

Diclofenac

Enteric coated delayed release diclofenac sodium tablet (50 mg)

Sponsors & Collaborators

  • Drug Delivery International Ltd

    collaborator INDUSTRY

  • BDD Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Howard NE Stevens · BDD Pharma Ltd

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714842 on ClinicalTrials.gov