Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate the bioequivalence, with respect to
risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg
orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their
tolerability and safety will be documented.
Phase:
Phase 1
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.