Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Enantyum® oral solution

25mg DKP.TRIS oral solution

Group Type OTHER

Enantyum® oral solution

Intervention Type DRUG

One dose of 25 mg DKP oral solution

Keral® tablet

25mg DKP.TRIS tablet

Group Type OTHER

Keral® tablet

Intervention Type DRUG

One dose of 25 mg DKP tablet

Interventions

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Enantyum® oral solution

One dose of 25 mg DKP oral solution

Intervention Type DRUG

Keral® tablet

One dose of 25 mg DKP tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes