Bioequivalence Trial of a New Opioid Combination Compared to Reference

This study has been completed.

First Received: March 28, 2007 Last Updated: July 5, 2007 History of Changes

Sponsored by:	Grünenthal GmbH
Information provided by:	Grünenthal GmbH
ClinicalTrials.gov Identifier:	NCT00460785

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Opioid	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:

Secondary Outcome Measures:

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460785

Sponsors and Collaborators

Grünenthal GmbH

Investigators

Principal Investigator:

Wolfgang Timmer, Dr.

CRS Mannheim

More Information

No publications provided

Study ID Numbers:	544506
Study First Received:	March 28, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00460785 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Central Nervous System Depressants
Peripheral Nervous System Agents
Analgesics
Healthy
Analgesics, Opioid

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 04, 2009