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NCT01981278 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants
A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT01981278 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 63 participants.
The verdict
NCT01981278, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.
Interventions
- DRUG Tapentadol ER 250-mg TRF tablet
- DRUG Tapentadol ER 250-mg PR2 tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 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 NCT01981278
The ClinicalTrials.gov registry entry for NCT01981278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 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 ER 250-mg TRF tablet is the first listed.
NCT01981278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01981278 about?
NCT01981278 is a clinical study titled "A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants". The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR...
What is the current status of trial NCT01981278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2010-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01981278?
The interventions under investigation include: Tapentadol ER 250-mg TRF tablet (DRUG), Tapentadol ER 250-mg PR2 tablet (DRUG).
Who is sponsoring clinical trial NCT01981278?
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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