Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02209454

Enrollment

Registered

2014-08-06

Start date

2014-04-30

Completion date

2014-06-30

Last updated

2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Dexketoprofen, Bioavailability, Comparative, Pharmacokinetic

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.

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).

Interventions

DRUGEnantyum® oral solution

One dose of 25 mg DKP oral solution

DRUGKeral® tablet

One dose of 25 mg DKP tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).	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.
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).	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).

Secondary

Measure	Time frame	Description
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).	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.
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).	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.
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).	AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Entire Study Population Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.	26
Total	26

Withdrawals & dropouts

Period	Reason	FG000	FG001
Second Period	Adverse Event	1	0

Baseline characteristics

Characteristic	Entire Study Population
Age, Continuous	28.9 years STANDARD_DEVIATION 6.39
Region of Enrollment United Kingdom	26 participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / 25	7 / 26
serious Total, serious adverse events	0 / 25	0 / 26

Outcome results

Primary

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).