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Norspan Transdermal Patches Study in Osteoarthritis Patients

NCT01643759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-07-08

No results posted yet for this study

Summary

This is a single center, open label, randomized, parallel group single dose pharmacokinetic (PK) study.

Conditions

  • Osteoarthritis Disorders

Interventions

DRUG

buprenorphine

The subjects will be randomized to receive either a single dose of BTDS 5, or BTDS 10, or BTDS 20 for 7 days. Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t:pg•hr/ml-Area under the plasma concentration-time curve frame: predose,6,12,24,36,48,60,72,96,120,144,168,169,170,171,172,174,180,192,216,240 hours post-dose.AUC0-inf:pg•hr/ml-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: pg/ml-Maximum observed plasma buprenorphine concentration. Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of buprenorphine elimination.

Sponsors & Collaborators

  • Mundipharma (China) Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Mundipharma China Ltd. · Mundipharma China Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-03-31

Countries

  • China

Study Locations

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 NCT01643759 on ClinicalTrials.gov