MedTrace Logo

To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules

NCT02117141 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-11-10

No results posted yet for this study

Summary

* Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states
* Evaluate the safety and tolerability of the test compound administered orally

Conditions

  • Healthy

Interventions

DRUG

HC-ER 20 mg capsule (fasted)

Single oral dose HC-ER 20 mg capsule after overnight fast (fasted)

DRUG

HC-ER 20 mg capsule (fed)

Single oral dose HC-ER 20 mg capsule after high fat meal (fed)

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • A. Johnston Stewart, MB, MRCGP · Zogenix, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2002-06-30
Completion
2002-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117141 on ClinicalTrials.gov