Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Orexigen Therapeutics, Inc
Treatments:
Bupropion Bupropion hydrochloride, naltrexone hydrochoride drug combination Naltrexone