NCT02209454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 9, 2015

Completed
Last Updated

July 9, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

August 4, 2014

Results QC Date

May 27, 2015

Last Update Submit

June 16, 2015

Conditions

Acute Pain

Keywords

DexketoprofenBioavailabilityComparativePharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • Cmax

    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)

    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 Outcomes (3)

  • AUC(0-∞)

    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

    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

    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).

Study Arms (2)

Enantyum® oral solution

OTHER

25mg DKP.TRIS oral solution

Drug: Enantyum® oral solution

Keral® tablet

OTHER

25mg DKP.TRIS tablet

Drug: Keral® tablet

Interventions

Enantyum® oral solutionDRUG

One dose of 25 mg DKP oral solution

Enantyum® oral solution
Keral® tabletDRUG

One dose of 25 mg DKP tablet

Keral® tablet

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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-

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research Limited

Merthyr Tydfil, UK, CF48 4DR, United Kingdom

Location

MeSH Terms

Conditions

Acute Pain

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Corporate Director of Clinical Research
Organization
Menarini Ricerche S.p.A.
acapriati@menarini-ricerche.it
0555680

Study Officials

  • Girish Sharma, MBBS

    Simbec Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 6, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 9, 2015

Results First Posted

July 9, 2015

Record last verified: 2015-05

Locations

GB(1)