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Lofexidine Food Effect Study in Healthy Volunteers

NCT01437306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-02-23

No results posted yet for this study

Summary

The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured by US WorldMeds, LLC.

Conditions

  • Healthy

Interventions

DRUG

Lofexidine HCl

400 mcg (2 x 200 mcg tablets) administered orally as a single dose

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • USWM, LLC (dba US WorldMeds)

    lead INDUSTRY

Principal Investigators

  • Charles W Gorodetzky, MD, PhD · US WorldMeds

  • James A Longstreth, PhD · US WorldMeds

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
2011-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01437306 on ClinicalTrials.gov