Bioequivalence Trial of a New Opioid Combination Compared to Reference

Grünenthal

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Opioid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460785

544506

Details and patient eligibility

About

The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Standard Phase I
• Cyp 2D6 extensive metabolizers

Exclusion criteria

• Standard Phase I
• Contraindications of current reference tablet SmPC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)