Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

June 16, 2015 updated by: Menarini Group

Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum® Oral Solution vs. Keral® Tablets in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted in 1 site and included 26 successfully screened and randomized healthy subjects(12 female and 14 male).

The study consisted of:

  • Screening Visit (performed within 3 weeks prior to 1st PK study session), for the evaluation of study eligibility.
  • Two pharmacokinetic (PK) study sessions, separated by a minimum of a 7 day washout period, including the administration of one out of 2 study treatments at each study session (namely 25mg DKP.TRIS given as Enantyum® oral solution or Keral® tablet) according to the sequence as per randomisation list, and blood sampling for PK assessment on plasma at pre-defined time up to 24 hours post-dose.
  • End of Study Visit (7-10 days after last treatment administration).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • Merthyr Tydfil, UK, United Kingdom, CF48 4DR
        • Simbec Research Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI) between 18 Kg/m2 and 28 Kg/m2-

Exclusion Criteria:

  • History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs (aspirin, ibuprofen etc).
  • Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs.
  • Surgery within previous 6 months, or blood loss > 400 mL within previous 3 months.
  • Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
  • History of clinically significant alcohol, medicine or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enantyum® oral solution
25mg DKP.TRIS oral solution
Drug: Enantyum® oral solution
One dose of 25 mg DKP oral solution
Other: Keral® tablet
25mg DKP.TRIS tablet
Drug: Keral® tablet
One dose of 25 mg DKP tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.
Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
AUC(0-t)
Time Frame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).
Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC(0-∞)
Time Frame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.
Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
Tmax
Time Frame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).
Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
t1/2
Time Frame: Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).
AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.
Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Group

Collaborators

Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD 303/25652(DKP-BE-SOL)
  • 2014-000371-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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