ClinicalTrials.gov record
Completed Phase 1 Interventional Accepts healthy volunteers

A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

ClinicalTrials.gov ID: NCT01758978

Public ClinicalTrials.gov record NCT01758978. 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.

ClinicalTrials.gov public records Last synced May 20, 2026, 10:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 30-mg and One 60-mg Hydrocodone Bitartrate Extended-Release Tablet

Study identification

NCT ID
NCT01758978
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Industry
Enrollment
54 participants

Conditions and interventions

Conditions

Interventions

  • 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

Drug

Eligibility (public fields only)

Age range
18 Years to 45 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
Nov 30, 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012
Last update posted
Mar 19, 2013

2012 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Teva Investigational Site 10471 Austin Texas

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 NCT01758978, 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 Mar 19, 2013 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01758978 live on ClinicalTrials.gov.

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