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Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects

NCT00812305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2010-09-08

No results posted yet for this study

Summary

Review differences between how a healthy person and how a person with liver problems handles the study drug.

Conditions

  • Pain
  • Hepatic Impairment

Interventions

DRUG

SKY0402 300mg in healthy patients

SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients

DRUG

SKY0402 300mg in hepatically impaired patients

SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Janusz Rupinski · Pharm-Olam International Polska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00812305 on ClinicalTrials.gov