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

NCT02259179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-12-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Senior Vice President Head of Global Development · Orexigen Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259179 on ClinicalTrials.gov