Conditions: Healthy
Keywords: Healthy subjects Opioid Transdermal
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.

Detailed description:
To assess the pharmacokinetics of buprenorphine and its metabolites (nor-buprenorphine, buprenorphine 3 glucuronide and nor-buprenorphine glucuronide) in the presence and absence of ketoconazole.

Safety evaluation of BTDS and ketoconazole in healthy subjects.

Arms:
arm 1: BTDS 10 with ketoconazole 200 mg tablets twice daily in period 1 and BTDS 10 with ketoconazole placebo tablets twice daily in period 2. arm 2: BTDS 10 with ketoconazole placebo tablets twice daily in period 1 and BTDS 10 with ketoconazole 200 mg twice daily in period 2.

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Ketoconazole tablet intervention 3: Placebo to match ketoconazole tablet
Intervention descriptions: intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Ketoconazole 200 mg tablets taken orally twice daily. intervention 3: Placebo to match ketoconazole 200 mg tablets taken orally twice daily.

Protocol document: