In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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