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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
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This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups.
This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment Order: Test, Reference, Comparator |
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| 2 | Experimental | Treatment Order: Test, Comparator, Reference |
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| 3 | Experimental | Treatment Order: Reference, Test, Comparator |
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| 4 | Experimental | Treatment Order: Reference, Comparator, Test |
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| 5 | Experimental | Treatment Order: Comparator, Test, Reference |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test - RB ibuprofen acid orodispersible tablets | Drug | RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t. | The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis 0-12hrs |
| Cmax - the maximum observed plasma concentration. | The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis 0-12hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t. | The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis 0-12hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Overall proportion of subjects with adverse events (AEs), i.e. the occurrence of one or more AEs per subject | Through study completion - Screening to study follow-up (approx 6 weeks) | |
| Change from baseline in oral temperature. | Measured in degrees Celcius |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annelize Koch, MBBS | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research | Merthyr Tydfil | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31202508 | Derived | Sugar D, Francombe D, da Silva T, Hanid S, Hutchings S. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers. Clin Ther. 2019 Aug;41(8):1486-1498. doi: 10.1016/j.clinthera.2019.04.040. Epub 2019 Jun 12. |
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|
| 6 | Experimental | Treatment Order: Comparator, Reference, Test |
|
| Reference - RB Nurofen ibuprofen acid tablets | Drug | RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral. |
|
| Comparator - Dolormin ibuprofen lysine tablets | Drug | Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral. |
|
| Cmax - the maximum observed plasma concentration. | The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis 0-12hrs |
| Kel - Elimination rate constant | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| AUC0-inf - Area under the plasma concentration-time curve from administration to infinity | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| AUCR - Ratio AUC0-t/AUC0-inf | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| Tmax - Time until Cmax is first achieved | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| T1/2 - Plasma concentration (elimination) half-life | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| Cn - The plasma concentration at each planned nominal time point. | Secondary endpoint for Test, Reference and Comparator products | PK Analysis 0-12hrs |
| Through study completion - Screening to study follow-up (approx 6 weeks) |
| Change from baseline in resting heart rate. | Measured in beats per minute | Through study completion - Screening to study follow-up (approx 6 weeks) |
| Change from baseline in resting blood pressure.. | Measured in mmHg | Through study completion - Screening to study follow-up (approx 6 weeks) |
| Change from baseline in standard haematology testing. | Through study completion - Screening to study follow-up (approx 6 weeks) |
| Change from baseline in standard biochemistry testing. | Through study completion - Screening to study follow-up (approx 6 weeks) |
| Change from baseline in standard urinary testing. | Through study completion - Screening to study follow-up (approx 6 weeks) |