MedTrace Logo

Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

NCT02209454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-07-09

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.

Conditions

  • Acute Pain

Interventions

DRUG

Enantyum® oral solution

One dose of 25 mg DKP oral solution

DRUG

Keral® tablet

One dose of 25 mg DKP tablet

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Girish Sharma, MBBS · Simbec Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02209454 on ClinicalTrials.gov