Norspan Transdermal Patches Study in Osteoarthritis Patients

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Disorders
• Intervention / Treatment: Drug: buprenorphine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Investigational Site: Peking Union Medical Hospital(PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: buprenorphine transdermal system

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.; Other Names: Norspan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: osteoarthritis disorders
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BP08-CN-002