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

NCT01310296 Phase 1 COMPLETED

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.

Details

Lead sponsor	USWM, LLC (dba US WorldMeds)
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2011-07
Completion	2011-08

Conditions

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

Interventions

• Lofexidine hydrochloride
• Lofexidine hydrochloride

Primary outcomes

• Mass Balance — plasma, urine, and fecal samples up to 216 hours post dose
  To determine the mass balance recovery of orally administered lofexidine hydrochloride

Countries

United States