NCT03280095

Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects

A Randomised, Open-label, Three-treatment, Single Dose, Crossover Study Investigating the Bioequivalence of Co-codamol 15/500mg Capsules With a Co-codamol 30/500mg Tablet in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Galen Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	co-codamol 15mg/500mg capsule
DRUG	co-codamol 30mg/500mg tablet

Timeline

• Start date: 2014-09-23
• Primary completion: 2014-12-12
• Completion: 2014-12-12
• First posted: 2017-09-12
• Last updated: 2017-09-12

Locations

1 site across 1 country: United Kingdom