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Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment

NCT02244762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-11-10

No results posted yet for this study

Summary

Determine the influence of renal impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

Conditions

  • Renal Impairment

Interventions

DRUG

20 mg HC-ER

1-72 hours

DRUG

20 mg HC-ER

1-72 hours

DRUG

20 mg HC-ER

1-72 hours

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth Lasseter, MD · Zogenix, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

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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 NCT02244762 on ClinicalTrials.gov