Trials / Completed

CompletedNCT01310296

Lofexidine ADME & Mass Balance in Volunteers

A Single-Center, Open-Label, Two-Period, Two-Treatment, Randomized Sequence Study 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

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 12 (actual)

Sponsor: USWM, LLC (dba US WorldMeds) · Industry
Sex: All
Age: 18 Years – 50 Years
Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

Start date: 2011-07-01
Primary completion: 2011-08-01
Completion: 2011-08-01
First posted: 2011-03-08
Last updated: 2017-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01310296. Inclusion in this directory is not an endorsement.