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Completed

NCT Number: NCT01259102

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ohio State University Department of Pharmacology

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine transdermal patch

Drug

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

Other names: Butrans™

Primary outcomes

  1. Period 1: AUC0-3d

    Time frame: 0 to 3 days (72 hours)

    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)].

  2. Period 2: AUC0-3d.

    Time frame: 0 to 3 days

    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).

  3. Period 1: Cmax0-3d

    Time frame: 0 to 3 days

    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.

  4. Period 2: Cmax0-3d

    Time frame: 0 to 3 days

    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 outcomes

  1. Period 1: AUC0-7d.

    Time frame: 0 to 7 days

    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.

  2. Period 2: AUC0-7d

    Time frame: 0 to 7 days

    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.

  3. Period 1: Cmax0-7

    Time frame: 0 to 7 days

    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.

  4. Period 2: Cmax0-7d

    Time frame: 0 to 7 days

    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.

  5. Period 1: Tmax0-7d.

    Time frame: 0 to 7days

    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.

  6. Period 2: Tmax0-7d.

    Time frame: 0 to 7 days

    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.

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Dec 13, 2010
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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