MedTrace Logo

Lofexidine ADME & Mass Balance in Volunteers

NCT01310296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-26

No results posted yet for this study

Summary

The purpose of this study is to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine.

Conditions

  • Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product

Interventions

DRUG

Lofexidine hydrochloride

Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine

DRUG

Lofexidine hydrochloride

Single Dose = 200 μg lofexidine in phosphate-buffered saline administered intravenously via infusion pump at a rate of 1 μg/min for 200 min

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • USWM, LLC (dba US WorldMeds)

    lead INDUSTRY

Principal Investigators

  • James A Longstreth, PhD · US WorldMeds

  • Charles W Gorodetzky, MD, PhD · US WorldMeds

  • Mark Leibowitz, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01310296 on ClinicalTrials.gov