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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Purdue Pharma LP

ClinicalTrials.gov Identifier:

NCT01259102

First received: December 10, 2010

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 10, 2010
Last Updated Date	August 27, 2012
Start Date ^ICMJE	November 2000
Primary Completion Date	March 2001 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 13, 2011)	Period 1: AUC0-3d [ Time Frame: 0 to 3 days (72 hours) ] [ Designated as safety issue: No ] Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)]. Period 2: AUC0-3d. [ Time Frame: 0 to 3 days ] [ Designated as safety issue: No ] Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d. AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). Period 1: Cmax0-3d [ Time Frame: 0 to 3 days ] [ Designated as safety issue: No ] Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug. Period 2: Cmax0-3d [ Time Frame: 0 to 3 days ] [ Designated as safety issue: No ] Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug.
Original Primary Outcome Measures ^ICMJE (submitted: December 10, 2010)	AUC0-3d and Cmax0-3d [ Time Frame: Multiple blood samples were collected for each BTDS patch wear ] [ Designated as safety issue: No ] AUC0-3d and Cmax0-3d for the purpose of determining the minimum application site rest periods that ensured that reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug.
Change History	Complete list of historical versions of study NCT01259102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 13, 2011)	Period 1: AUC0-7d. [ Time Frame: 0 to 7 days ] [ Designated as safety issue: No ] Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. Period 2: AUC0-7d [ Time Frame: 0 to 7 days ] [ Designated as safety issue: No ] Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d. AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal. Period 1: Cmax0-7 [ Time Frame: 0 to 7 days ] [ Designated as safety issue: No ] Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. Period 2: Cmax0-7d [ Time Frame: 0 to 7 days ] [ Designated as safety issue: No ] Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d. Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile. Period 1: Tmax0-7d. [ Time Frame: 0 to 7days ] [ Designated as safety issue: No ] Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax. Period 2: Tmax0-7d. [ Time Frame: 0 to 7 days ] [ Designated as safety issue: No ] Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d. Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Buprenorphine transdermal patch Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear. Other Name: Butrans™
Study Arm (s)	Experimental: No Rest BTDS 10 with no application site rest period prior to application of second BTDS Intervention: Drug: Buprenorphine transdermal patch Experimental: 7-Day Rest BTDS 10 with 7-day rest period prior to application of second BTDS Intervention: Drug: Buprenorphine transdermal patch Experimental: 14-Day Rest BTDS 10 with 14-day rest period prior to application of second BTDS Intervention: Drug: Buprenorphine transdermal patch Experimental: 21-Day Rest BTDS 10 with 21-day rest period prior to application of second BTDS Intervention: Drug: Buprenorphine transdermal patch Experimental: 28-Day Rest BTDS 10 with 28-day rest period prior to application of second BTDS Intervention: Drug: Buprenorphine transdermal patch
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	70
Completion Date	March 2001
Primary Completion Date	March 2001 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01259102
Other Study ID Numbers ^ICMJE	BUP1002
Has Data Monitoring Committee	No
Responsible Party	Purdue Pharma LP
Study Sponsor ^ICMJE	Purdue Pharma LP
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Purdue Pharma LP
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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