Clinical trial NCT01259102: Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Official title: A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subjects
Opioid
Transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

Detailed description: The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.

Eligibility criteria: Inclusion Criteria Include:

* Males and females 18 to 45 years of age, inclusive.
* Weight of 60 to 100 kilograms (kg) \[132-220 pounds (lb)\] and within 15% of optimum for height and body frame.
* In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
* Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
* Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
* Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

* A history of hypersensitivity to opioid or psychotropic drugs.
* A history of recurrent seizures or syncope.
* Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
* Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count \[ANC\] \<1000/mm3 or thrombocytopenia (platelet \<150,000/mm3).
* Positive results of urine drug screen or urine cotinine (consistent with active smoking).
* A history of substance or alcohol abuse within the past 5 years.
* Females who are nursing.
* Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: Period 1: AUC0-3d
timeFrame: 0 to 3 days (72 hours)
measure: Period 2: AUC0-3d.
timeFrame: 0 to 3 days
measure: Period 1: Cmax0-3d
timeFrame: 0 to 3 days
measure: Period 2: Cmax0-3d
timeFrame: 0 to 3 days
Secondary outcomes:
measure: Period 1: AUC0-7d.
timeFrame: 0 to 7 days
measure: Period 2: AUC0-7d
timeFrame: 0 to 7 days
measure: Period 1: Cmax0-7
timeFrame: 0 to 7 days
measure: Period 2: Cmax0-7d
timeFrame: 0 to 7 days
measure: Period 1: Tmax0-7d.
timeFrame: 0 to 7days
measure: Period 2: Tmax0-7d.
timeFrame: 0 to 7 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Department of Pharmacology
state: Ohio
Study officials:
References: