Bioequivalence Study of Eudorlin® Extra and Two Reference Ibuprofen Formulations
Author Information
Author(s): Bramlage Peter, Goldis Adrian
Primary Institution: Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, Technical University Dresden
Hypothesis
The study aims to determine the bioavailability and bioequivalence of Eudorlin® extra compared to Nurofen® forte and Migränin® after single dose administration.
Conclusion
Eudorlin® extra is bioequivalent to Nurofen® forte and Migränin® in terms of absorption rate and extent, but reaches higher peak plasma concentrations more quickly.
Supporting Evidence
- Eudorlin® extra showed a higher Cmax compared to both reference products.
- The time to maximum plasma concentration (tmax) was shorter for Eudorlin® extra.
- All pharmacokinetic parameters were within the acceptance range set by EMEA.
Takeaway
This study shows that a new ibuprofen product works just as well as two other brands, but it gets into your system faster and stronger.
Methodology
A randomized, open label, multiple sequence cross-over study with a wash-out period of 7–10 days was conducted.
Potential Biases
There may be a risk of bias due to the open-label design.
Limitations
The study had a small sample size and only included healthy volunteers.
Participant Demographics
60 healthy volunteers, 41 male and 19 female, aged 20 to 45 years.
Statistical Information
P-Value
0.0014
Confidence Interval
90% CI for AUC0-t(last) and AUC0-∞ within 80-125%; Cmax within 75-133%
Statistical Significance
p<0.0001
Digital Object Identifier (DOI)
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