Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
- Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet
(Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under
fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single
administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg
ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.
- Study to determine the relative bioavailability of ibuprofen following single
administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg
ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet
(Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.
- Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three
formulations.