In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers

Summary

The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not

Timeline

Start

2005-10

Primary completion

2005-12

Completion

—

Drugs

Indications

No indication recorded.