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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 is a Phase 1 study that has completed, run by Orexigen Therapeutics. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02259179
The ClinicalTrials.gov registry entry for NCT02259179 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orexigen Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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