A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
Public ClinicalTrials.gov record NCT03137017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate and Acetaminophen (a New Abuse Deterrent Tablet and a Marketed Tablet) Administered Under Fasted and Fed Conditions in Healthy Male and Female Adult Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of a new and a marketed tablet formulation under fasted and fed conditions in healthy adults. This is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral dose Phase I trial in 32 healthy male and female subjects. The trial will consist of an Enrollment Visit, 4 treatment periods (each lasting approximately 60 hours) separated by 3 washout periods (each lasting at least 7 days), and a Final Examination.
Study identification
- NCT ID
- NCT03137017
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2017
- Primary completion
- Oct 31, 2017
- Completion
- Oct 31, 2017
- Last update posted
- Jul 20, 2017
2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| US001: PRA Health Sciences | Lenexa | Kansas | 66219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03137017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03137017 live on ClinicalTrials.gov.