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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
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This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30 mg pseudoephedrine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment Order: Test, Comparator 1, Comparator 2 |
|
| 2 | Experimental | Treatment Order: Test, Comparator 2, Comparator 1 |
|
| 3 | Experimental | Treatment Order: Comparator 1, Test, Comparator 2 |
|
| 4 | Experimental | Treatment Order: Comparator 1, Comparator 2, Test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules | Drug | 2 x 200 mg ibuprofen & 30 mg pseudoephedrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pseudoephedrine AUC0-t for Test vs. Comparator 1. | The Test and Comparator 1 will be considered similar if for pseudoephedrine, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis: 0-48hrs |
| Pseudoephedrine Cmax for Test vs. Comparator 1. | The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis: 0-48hrs |
| Ibuprofen AUC0-t for Test vs. Comparator 2. | The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis: 0-48hrs |
| Ibuprofen Cmax for Test vs. Comparator 2. | The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis: 0-48hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Ibuprofen AUC0-t for Test vs. Comparator 1. | The Test and Comparator 1 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: • Cmax for ibuprofen (in the context of the Test vs. Comparator 1 comparison) |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of Adverse Events. | Through study completion - Screening to study follow-up (Approx 8 weeks) | |
| Change from baseline in oral temperature. | Measured in degrees Celcius | Through study completion - Screening to study follow-up (Approx 8 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Adams, MBBS | Simbec Research | Principal Investigator |
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| 5 | Experimental | Treatment Order: Comparator 2, Test, Comparator 1 |
|
| 6 | Experimental | Treatment Order: Comparator 2, Comparator 1, Test |
|
| Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets | Drug | 2 x 200 mg ibuprofen & 30 mg pseudoephedrine |
|
| Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules | Drug | 2 x 200 mg solubilised ibuprofen |
|
| PK Analysis: 0-48hrs |
| Ibuprofen Cmax for Test vs. Comparator 1. | The Test and Comparator 1 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%: | PK Analysis: 0-48hrs |
| Assessment of how fast the ibuprofen from the Test product starts to be absorbed and how quickly it reaches the therapeutic level. | T8.4 - time to reach the therapeutic level (8.4 µg/ml) for ibuprofen. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | Cn - the plasma concentration of an active at each planned nominal time-point. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | AUC0-inf - Area under the plasma concentration-time curve from administration to infinity. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | administration to infinity. AUCR - ratio AUC0-t / AUC0-inf. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | Tmax -Time until Cmax is first achieved. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | Kel - elimination rate constant. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | T1/2 - plasma concentration half-life. | PK Analysis: 0-48hrs |
| Pharmacokinetic parameters will be assessed as secondary endpoints. | Tlag - time between administration and the beginning of absorption of ibuprofen. This will be calculated only for the Test. | PK Analysis: 0-48hrs |
| Change from baseline in resting heart rate. | Measured in beats per minute | Through study completion - Screening to study follow-up (Approx 8 weeks) |
| Change from baseline in resting blood pressure. | Measured in mmHg | Through study completion - Screening to study follow-up (Approx 8 weeks) |
| Change from baseline in haematology testing. | Through study completion - Screening to study follow-up (Approx 8 weeks) |
| Change from baseline in biochemistry testing. | Through study completion - Screening to study follow-up (Approx 8 weeks) |
| Change from baseline in urinary testing. | Through study completion - Screening to study follow-up (Approx 8 weeks) |
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D007052 | Ibuprofen |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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