Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|ClinicalTrials.gov Identifier: NCT03018015|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.
In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.
All 3 immediate release preparations contain 400 mg ibuprofen.
|Condition or disease||Intervention/treatment||Phase|
|Bioequivalence||Drug: Ibuprofen 400 mg oral powder Drug: Ibuprofen 400 mg film-coated tablet Drug: Ibuprofen 400 mg soft capsule||Phase 1|
The clinical trial will be performed in a single centre, open-label, randomised (order of treatments), balanced, 3-period, 6-sequence, single dose change-over design with administration under fasting conditions separated by a washout period of at least 2 treatment-free days.
Blood sample collection will be performed over 16 h after administration. This time is considered adequate to characterise plasma concentration vs. time profiles long enough for reliable estimation of the extent of absorption, i.e. the AUC derived from measurements is expected to cover at least 80 % of the AUC extrapolated to infinity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterisation of Relative Bioavailability of a Newly Developed Ibuprofen Oral Powder Formulation in Comparison With Two Marketed Reference Products in a Single Dose, 3-period-crossover Design Under Fasting Conditions; Controlled, Open-label, Randomised Study With Bioequivalence Assessment|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Ibuprofen 400 mg oral powder
oral fasted administration of 1 sachet of Ibuprofen 400 mg oral powder (Hermes Arzneimittel GmbH, Germany), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg oral powder
Active Comparator: Brufen 400 mg film-coated tablets
oral fasted administration of Brufen 400 mg film-coated tablets (Abbott Scandinavia AB, Sweden), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg film-coated tablet
Active Comparator: Spalt forte 400 mg Weichkapseln
oral fasted administration of Spalt forte 400 mg Weichkapseln (Pfizer Consumer Healthcare GmbH, Germany), containing 400 mg ibuprofen
Drug: Ibuprofen 400 mg soft capsule
- Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen [ Time Frame: 16 hours interval ]
- Peak Plasma Concentration (Cmax) for ibuprofen [ Time Frame: 16 hours interval ]
- Number of participants with treatment-related adverse events [ Time Frame: from first dose until discharge of the subject (approx. 2 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018015
|SocraTec R&D GmbH Clinical Pharmacology Unit|
|Erfurt, Thüringen, Germany, 99084|
|Principal Investigator:||Cornelius Koch, MD||SocraTec R&D GmbH, Clinical Pharmacology Unit|