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

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

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.