INTAC® maintains the efficacy of FDA-approved drugs without compromising safety and tolerability
Different approaches for a clinical trial program are possible for bringing ER / IR ADF products onto the market.
Clinical trials validating INTAC® bioequivalence
In clinical trials, excellent congruence of the serum concentration time profiles are observed for INTAC® and conventional marketed IR and ER formulations.
Results of INTAC® IR bioavailability trial1
Results of INTAC® ER bioavailability bridging program2
Geometric mean concentrations of analgesic drug [ng/mL] versus time [h] following SD and MD oral administration of test and reference (n=44).
a For some products post-marketing reports of difficulty in swallowing the tablets have been noted
1. Stahlberg HJ, Brett M, Ossig J, Philipp AA, Schwier S. Bridging from conventional marketed immediate release formulations to new tamper resistant alternatives. Clinical poster. Grünenthal GmbH; Aachen, Germany.
2. Stahlberg HJ, Brett M, Galia E, Ossig J, Wenge B. Bridging from conventional marketed extended release formulations to new tamper resistant alternatives. Clinical poster. Grünenthal GmbH; Aachen, Germany.