Bioequivalence Trial of a New Opioid Combination Compared to Reference

Phase 1CompletedNCT00460785

Grünenthal GmbH32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OpioidDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Standard Phase I * Cyp 2D6 extensive metabolizers Exclusion Criteria: * Standard Phase I * Contraindications of current reference tablet SmPC

Outcomes

Primary Outcomes

Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.

Secondary Outcomes

Descriptive, e. g. safety/tolerability of Test comparable to Reference

Data from ClinicalTrials.gov

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