drugset / Trial / NCT01408394

Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam

NCT01408394

Phase 1 Completed 16 enrolled Emalex Biosciences Inc. Psyadon Pharma · collab
RandomizedCrossoverSingle-blindTreatment

Summary

Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible diseases. To date, all clinical studies have been done using the ecopipam immediate release (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been produced that may be able to improve its effectiveness and reduce its side effects. The main purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when given as single oral dose in healthy volunteers.

Timeline

Start
2011-08
Primary completion
2012-02
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ecopipam Small molecule 90 mg Oral
Comparator Ecopipam Small molecule 100 mg Oral
Comparator Ecopipam Small molecule 180 mg Oral

Indications

No indication recorded.