NCT02259179

Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers

A Phase 1 Bioequivalence Study of Naltrexone SR/Bupropion SR Combination Trilayer Tablets From Two Manufacturers in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
DRUG	Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-10-08
• Last updated: 2014-12-11

Locations

1 site across 1 country: United States