Conditions: Healthy
Keywords: Healthy subjects Opioid Transdermal
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: yes

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.

Arms:
arm 1: BTDS 10 with no application site rest period prior to application of second BTDS arm 2: BTDS 10 with 7-day rest period prior to application of second BTDS arm 3: BTDS 10 with 14-day rest period prior to application of second BTDS arm 4: BTDS 10 with 21-day rest period prior to application of second BTDS arm 5: BTDS 10 with 28-day rest period prior to application of second BTDS

Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Protocol document: