NCT03018015

Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SocraTec R&D GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg oral powder
DRUG	Ibuprofen 400 mg film-coated tablet
DRUG	Ibuprofen 400 mg soft capsule

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2017-01-11
• Last updated: 2017-01-11

Locations

1 site across 1 country: Germany