Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02259179 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
A Phase 1 study, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02259179: Completed Phase 1 study, sponsored by Orexigen Therapeutics.
NCT02259179 is a Phase 1 study that has completed, run by Orexigen Therapeutics. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02259179, a Phase 1 study, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
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.
Primary Outcome
Maximum observed plasma concentration
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02259179 record still lists
NCT02259179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) is the first listed.
NCT02259179 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02259179 about?
NCT02259179 is a clinical study titled "Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers". 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 evaluat...
What is the current status of trial NCT02259179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2014-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02259179?
The interventions under investigation include: 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) (DRUG).
Who is sponsoring clinical trial NCT02259179?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02259179's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia