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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Buprenorphine transdermal patch

• Registration Number: NCT01259102
• Lead Sponsor: Purdue Pharma LP

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 Timeline

• Study Start: 2000-11
• Primary Completion: 2001-03
• Study Completion: 2001-03
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Results First Submitted: 2011-01-13
• Results First Submitted QC: 2011-01-13
• Results First Posted: 2011-02-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14-Day Rest	Buprenorphine transdermal patch	BTDS 10 with 14-day rest period prior to application of second BTDS
21-Day Rest	Buprenorphine transdermal patch	BTDS 10 with 21-day rest period prior to application of second BTDS
No Rest	Buprenorphine transdermal patch	BTDS 10 with no application site rest period prior to application of second BTDS
7-Day Rest	Buprenorphine transdermal patch	BTDS 10 with 7-day rest period prior to application of second BTDS
28-Day Rest	Buprenorphine transdermal patch	BTDS 10 with 28-day rest period prior to application of second BTDS

Primary Outcome Measures

Name	Time	Method
Period 1: AUC0-3d	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 \[The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)\].
Period 2: AUC0-3d.	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).
Period 1: Cmax0-3d	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.
Period 2: Cmax0-3d	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 Outcome Measures

Name	Time	Method
Period 1: AUC0-7d.	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.
Period 2: AUC0-7d	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.
Period 1: Cmax0-7	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.
Period 2: Cmax0-7d	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.
Period 1: Tmax0-7d.	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.
Period 2: Tmax0-7d.	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.

Trial Locations

Locations (1)

The Ohio State University Department of Pharmacology; 🇺🇸 Columbus, Ohio, United States