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NCT02019485 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects
A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT02019485 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 64 participants.
The verdict
NCT02019485, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg, prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted (without food) conditions.
Interventions
- DRUG Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)
- DRUG Tapentadol Prolonged-Release Formulation 2 (PR2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019485
The ClinicalTrials.gov registry entry for NCT02019485 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) is the first listed.
NCT02019485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02019485 about?
NCT02019485 is a clinical study titled "A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects". The purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg, prolonged-release formulation 2 (PR2) tablet use...
What is the current status of trial NCT02019485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2010-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT02019485?
The interventions under investigation include: Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) (DRUG), Tapentadol Prolonged-Release Formulation 2 (PR2) (DRUG).
Who is sponsoring clinical trial NCT02019485?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
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