Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Healthy
Interventions
DRUG

Lofexidine + Naltrexone

Lofexidine HCl (two 0.2 mg tablets) will be administered as a single oral dose (0.4 mg) on Day 1 and on Day 11.Commercially available naltrexone HCL tablets will be administered as a single oral 25 mg dose on Day 4 and as a single oral 50 mg dose on Days 5 through 13. On Day 11 administration of both naltrexone and lofexidine will occur. Dose administration times for each drug are to be standardized for all treatment days. The scheduling of the naltrexone dose is to be standardized so that the naltrexone dose is administered 2 hours after the lofexidine dose on Day 11 when both drugs are administered.

Trial Locations (1)

78217

Worldwide Clinical Trials, San Antonio

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

USWM, LLC (dba US WorldMeds)

INDUSTRY

NCT02446002 - Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects | Biotech Hunter | Biotech Hunter