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NCT01846455 · ClinicalTrials.gov registry record · Phase 4
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
A Phase 4 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT01846455 is a Phase 4 study that has completed, run by Indivior. The registered enrollment target is 43 participants.
The verdict
NCT01846455, a Phase 4 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
Interventions
- DRUG Promethazine
- DRUG 2.0mg Buprenorphine/0.5mg Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01846455
The ClinicalTrials.gov registry entry for NCT01846455 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Promethazine is the first listed.
NCT01846455 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01846455 about?
NCT01846455 is a clinical study titled "Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects". The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
What is the current status of trial NCT01846455?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2012-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01846455?
The interventions under investigation include: Promethazine (DRUG), 2.0mg Buprenorphine/0.5mg Naloxone (DRUG).
Who is sponsoring clinical trial NCT01846455?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
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