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

NCT03280095 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-12

No results posted yet for this study

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

DRUG

co-codamol 15mg/500mg capsule

DRUG

co-codamol 30mg/500mg tablet

Sponsors & Collaborators

  • Galen Limited

    lead INDUSTRY

Principal Investigators

  • David Bell, MD · BioKinetic Europe Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2014-12-12
Completion
2014-12-12

Countries

  • United Kingdom

Study Locations

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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 NCT03280095 on ClinicalTrials.gov