Trial Outcomes & Findings for Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations (NCT NCT02209454)
NCT ID: NCT02209454
Last Updated: 2015-07-09
Results Overview
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.
COMPLETED
PHASE1
26 participants
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).
2015-07-09
Participant Flow
Participant milestones
| Measure |
Reference IMP First, Then Test IMP
25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
|
Test IMP First, Then Reference IMP
25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
|
|---|---|---|
|
First Period
STARTED
|
13
|
13
|
|
First Period
COMPLETED
|
13
|
13
|
|
First Period
NOT COMPLETED
|
0
|
0
|
|
Washout Period a Minimum of a 7 Day
STARTED
|
13
|
13
|
|
Washout Period a Minimum of a 7 Day
COMPLETED
|
13
|
13
|
|
Washout Period a Minimum of a 7 Day
NOT COMPLETED
|
0
|
0
|
|
Second Period
STARTED
|
13
|
13
|
|
Second Period
COMPLETED
|
12
|
13
|
|
Second Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Reference IMP First, Then Test IMP
25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
|
Test IMP First, Then Reference IMP
25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
|
|---|---|---|
|
Second Period
Adverse Event
|
1
|
0
|
Baseline Characteristics
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=26 Participants
Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
|
|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 6.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).Population: Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).
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.
Outcome measures
| Measure |
Enantyum® Oral Solution
n=25 Participants
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 Participants
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
Cmax
|
3290.70 ng/mL
Interval 2996.0 to 3614.4
|
2785.90 ng/mL
Interval 2493.2 to 3113.0
|
PRIMARY outcome
Timeframe: 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).Population: Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).
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).
Outcome measures
| Measure |
Enantyum® Oral Solution
n=25 Participants
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 Participants
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
AUC(0-t)
|
3362.20 h*ng/mL
Interval 2986.2 to 3785.6
|
3372.00 h*ng/mL
Interval 3027.3 to 3755.9
|
SECONDARY outcome
Timeframe: 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).Population: Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).
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.
Outcome measures
| Measure |
Enantyum® Oral Solution
n=25 Participants
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 Participants
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
AUC(0-∞)
|
3473.00 h*ng/mL
Interval 3087.7 to 3906.4
|
3485.60 h*ng/mL
Interval 3135.3 to 3875.0
|
SECONDARY outcome
Timeframe: 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).Population: Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).
AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).
Outcome measures
| Measure |
Enantyum® Oral Solution
n=25 Participants
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 Participants
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
Tmax
|
0.25 h
Interval 0.17 to 0.67
|
0.50 h
Interval 0.25 to 1.25
|
SECONDARY outcome
Timeframe: 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).Population: Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).
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.
Outcome measures
| Measure |
Enantyum® Oral Solution
n=25 Participants
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 Participants
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
t1/2
|
1.34 h
Interval 1.23 to 1.45
|
1.30 h
Interval 1.2 to 1.41
|
Adverse Events
Enantyum® Oral Solution
Keral® Tablet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enantyum® Oral Solution
n=25 participants at risk
25mg DKP.TRIS oral solution
Enantyum® oral solution: One dose of 25 mg DKP oral solution
|
Keral® Tablet
n=26 participants at risk
25mg DKP.TRIS tablet
Keral® tablet: One dose of 25 mg DKP tablet
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 2 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Investigations
Hepatic enzyme increased
|
4.0%
1/25 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
0.00%
0/26 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Investigations
Serum ferritin decreases
|
4.0%
1/25 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
0.00%
0/26 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
0.00%
0/26 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/25 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
3.8%
1/26 • Number of events 1 • from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
|
Additional Information
Corporate Director of Clinical Research
Menarini Ricerche S.p.A.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place