Norspan Transdermal Patches Study in Osteoarthritis Patients

Mundipharma

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis Disorders

Treatments

Drug: buprenorphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01643759

BP08-CN-002

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.