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

NCT01408394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Ecopipam immediate release form

Tablet containing 100 mg of the immediate release form of ecopipam

DRUG

90 mg controlled release form

This is the 90 mg controlled release form

DRUG

180 mg controlled release form

This is the 180 mg controlled release capsule

Sponsors & Collaborators

  • Psyadon Pharma

    collaborator INDUSTRY

  • Emalex Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MB,ChB,FACP · SNBL Clinical Pharmacology Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408394 on ClinicalTrials.gov