Norspan Transdermal Patches Study in Osteoarthritis Patients

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

Detailed Description
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After up to 7-day screening period, Eligible Patients will be randomized to 1 of 3 treatment groups, and begin treatment with BTDS 5mg, 10mg,20mg for 7 days.Venous blood will be collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216, 240 h postdose respectively.Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, Tmax, t½.

Official Title
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A Single Dose PK Study of BTDS 5, 10, and 20 in Chinese Osteoarthritis Patients

Conditions
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Osteoarthritis Disorders

Intervention / Treatment
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* Drug: buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients volunteering for participation in the study. Male and female patients with diagnosis of osteoarthritis, age from 20 to 60 years. Body weight ≥ 50kg , and BMI range ≧ 18.5, ﹤ 30. Having the results within the following ranges and having been judged as eligible for the study participation by the investigator:Systolic blood pressure (supine), 90-140 mm Hg,Diastolic blood pressure (supine), 60-90 mm Hg, Armpit body temperature, 35.0-37.5 degree Celsius. Agreed not to use any medication (except vitamins or mineral supplements) during the course of the study. Have not smoked or chewed tobacco for at least 45 days prior to dosing with study drugs, and agree not to use tobacco products during the study. Females of childbearing potential must have a negative serum pregnancy test during screening visit and at check-in. Exclusion Criteria: Subjects who have been taking opioid analgesic formulations excess 7 days within 3 months of Visit 1. Subjects who have been taking CYP3A4 inhibitor or inducer within the last 1 month prior to the screening visit. Subjects who have been taking any medication including OTC (except vitamin and/or mineral supplements) within 7 days prior to the first dose of the trial product. Patients who have a current chronic disease(s), or who have a past history and high possibilities to relapse, in addition to their musculo-skeletal pain, requiring frequent analgesic therapy. Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis. Subject who have a past history of malignant neoplasm. Subjects with clinically unstable, active or symptomatic heart disease. Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on. Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs. History of frequent nausea or emesis regardless of etiology. Subjects who have a current or past history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period. Subjects scheduled for therapies within the study period which might effect study assessment. Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin during the Screening Period or who have severe impaired liver function. Subjects with serum creatinine > 2 mg/dL during the Screening Period or who have severe impaired renal function. Subjects with serum potassium < 3.5 mEq/L during the Screening Period. Subjects with positive result of anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis C virus antibody or qualitative syphilis tests. Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within 1 month prior to the start of the study. Subjects who have a history of supersensitivity to study drug. Subjects who participated in a clinical research study within 1 month of study entry. Subjects who participated previously in a BTDS study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: buprenorphine transdermal system<br>buprenorphine transdermal system | Drug: buprenorphine<br>* 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.<br>* Other names: Norspan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) |  | Pre-dose, 6hr, 12hr, 24hr, 36hr, 48hr, 60hr, 72hr, 96hr, 120hr, 144hr,168hr, 169hr, 170hr, 171hr, 172hr, 174hr, 180hr, 192hr, 216hr, 240hr post dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis disorders