Norspan Transdermal Patches Study in Osteoarthritis Patients

NCT01643759 | Completed Phase 1

• 1 other identifier: BP08-CN-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis Disorders

Keywords

osteoarthritis disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

buprenorphine transdermal system

EXPERIMENTAL

buprenorphine transdermal system

Drug: buprenorphine

Interventions

buprenorphine DRUG

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.

Also known as: Norspan

buprenorphine transdermal system

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Investigational Site: Peking Union Medical Hospital(PUMC)

Beijing, China

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mundipharma China Ltd.

  Mundipharma China Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: July 18, 2012
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

CN (1)