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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000371-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enantyum® oral solution | Other | 25mg DKP.TRIS oral solution |
|
| Keral® tablet | Other | 25mg DKP.TRIS tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enantyum® oral solution | Drug | One dose of 25 mg DKP oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-∞) | 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). |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Sharma, MBBS | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Limited | Merthyr Tydfil | UK | CF48 4DR | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
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| Washout Period a Minimum of a 7 Day |
| |||||||||||||
| Second Period |
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Twenty-six (26) subjects were randomized (14 male and 12 female) for 24 to complete the study. A total of 25 subjects (13 male and 12 female) completed the study. NOTE: Treatments were administered in a crossover manner, with the same population but one healthy subjects being exposed to the Reference and Test IMP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 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). |
|
from Screening Visit to End of Study Visit
Analyzed for the safety population (All subject receiving at least one administration of study treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enantyum® Oral Solution | 25mg DKP.TRIS oral solution Enantyum® oral solution: One dose of 25 mg DKP oral solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corporate Director of Clinical Research | Menarini Ricerche S.p.A. | 0555680 | 9990 | acapriati@menarini-ricerche.it |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
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| Keral® tablet |
| Drug |
One dose of 25 mg DKP tablet |
|
| Tmax |
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 | 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). |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Keral® Tablet | 25mg DKP.TRIS tablet Keral® tablet: One dose of 25 mg DKP tablet |
|
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| Secondary | AUC(0-∞) | 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 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). |
|
|
|
| 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). | 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). | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 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 | Tmax | AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax). | 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). | Posted | Median | Full Range | h | 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 | t1/2 | 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | h | 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). |
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|
|
| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | Keral® Tablet | 25mg DKP.TRIS tablet Keral® tablet: One dose of 25 mg DKP tablet | 0 | 26 | 7 | 26 |
| Hepatic enzyme increased | Investigations |
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| Serum ferritin decreases | Investigations |
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| Headache | Nervous system disorders |
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| Presyncope | Nervous system disorders |
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| Syncope | Nervous system disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
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| Sneezing | Respiratory, thoracic and mediastinal disorders |
|
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