Conditions: Hepatitis C
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

Brief summary:
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.

Detailed description:

Arms:
arm 1: patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day arm 2: patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.

Interventions: intervention 1: BI 201335 intervention 2: BI 201335
Intervention descriptions: intervention 1: BI 201335 for 9 days intervention 2: BI 201335 for 9 days

Protocol document: