Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Condition: Healthy
Intervention: Buprenorphine transdermal patch
Intervention description: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy subjects; Opioid; Transdermal

Summary:

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

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.