Norspan Transdermal Patches Study in Osteoarthritis Patients

Launched by MUNDIPHARMA (CHINA) PHARMACEUTICAL CO. LTD · Jul 17, 2012

Keywords

ClinConnect Summary

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.

Gender

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Eligibility criteria

• 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.