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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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Buprenorphine transdermal patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 70
Study Start Date: November 2000
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No Rest
BTDS 10 with no application site rest period prior to application of second BTDS
Drug: Buprenorphine transdermal patch
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other Name: Butrans™
Experimental: 7-Day Rest
BTDS 10 with 7-day rest period prior to application of second BTDS
Drug: Buprenorphine transdermal patch
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other Name: Butrans™
Experimental: 14-Day Rest
BTDS 10 with 14-day rest period prior to application of second BTDS
Drug: Buprenorphine transdermal patch
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other Name: Butrans™
Experimental: 21-Day Rest
BTDS 10 with 21-day rest period prior to application of second BTDS
Drug: Buprenorphine transdermal patch
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other Name: Butrans™
Experimental: 28-Day Rest
BTDS 10 with 28-day rest period prior to application of second BTDS
Drug: Buprenorphine transdermal patch
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Other Name: Butrans™

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259102

Locations
United States, Ohio
The Ohio State University Department of Pharmacology
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01259102     History of Changes
Other Study ID Numbers: BUP1002
Study First Received: December 10, 2010
Results First Received: January 13, 2011
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Healthy subjects
Opioid
Transdermal

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014