Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods

NCT ID: NCT01259102

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2001-03-31

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.

Conditions

Healthy

Keywords

Healthy subjects; Opioid; Transdermal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

No Rest

BTDS 10 with no application site rest period prior to application of second BTDS

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

7-Day Rest

BTDS 10 with 7-day rest period prior to application of second BTDS

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

14-Day Rest

BTDS 10 with 14-day rest period prior to application of second BTDS

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

21-Day Rest

BTDS 10 with 21-day rest period prior to application of second BTDS

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

28-Day Rest

BTDS 10 with 28-day rest period prior to application of second BTDS

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Interventions

Buprenorphine transdermal patch

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Intervention Type: DRUG

Other Intervention Names

Butrans™

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Ohio State University Department of Pharmacology

Columbus, Ohio, United States

Countries

United States

Other Identifiers

BUP1002

Identifier Type: -

Identifier Source: org_study_id