Bioequivalence Trial of a New Opioid Combination Compared to Reference

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Opioid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Standard Phase I
* Cyp 2D6 extensive metabolizers

Exclusion Criteria

* Standard Phase I
* Contraindications of current reference tablet SmPC

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Wolfgang Timmer, Dr.

Role: PRINCIPAL_INVESTIGATOR

CRS Mannheim

Other Identifiers

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544506

Identifier Type: -

Identifier Source: org_study_id