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NCT01758978 · ClinicalTrials.gov registry record · Phase 1
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01758978 is a Phase 1 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 54 participants.
The verdict
NCT01758978, a Phase 1 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release tablet.
Interventions
- DRUG a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01758978
The ClinicalTrials.gov registry entry for NCT01758978 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B). is the first listed.
NCT01758978 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01758978 about?
NCT01758978 is a clinical study titled "A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet". The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release tablet.
What is the current status of trial NCT01758978?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2012-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01758978?
The interventions under investigation include: a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B). (DRUG).
Who is sponsoring clinical trial NCT01758978?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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