A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.

This study has been completed.

First Received: January 19, 2006 Last Updated: March 5, 2008 History of Changes

Sponsored by:	Dey
Information provided by:	Dey
ClinicalTrials.gov Identifier:	NCT00280358

Purpose

The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.

Condition	Intervention	Phase
Healthy	Drug: Fluticasone Propionate Drug: Formoterol Fumarate	Phase I

MedlinePlus related topics: Urine and Urination

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Fluticasone propionate Fluticasone Arformoterol Tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Further study details as provided by Dey:

Primary Outcome Measures:

Levels of study medication in blood and urine.

Secondary Outcome Measures:

Safety/tolerability

Estimated Enrollment:	30
Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Non-smokers, BMI 18-29, no current medications

Exclusion Criteria:

Significant conditions or disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280358

Locations

United States, Kansas
Research Site
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

Dey

More Information

No publications provided

Responsible Party:	Dey, LP ( Director Clinical Affairs )
Study ID Numbers:	191-072
Study First Received:	January 19, 2006
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00280358 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

Fluticasone
Formoterol
PK Study
Pharmacokinetics

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Anti-Asthmatic Agents
Formoterol

Fluticasone
Anti-Allergic Agents
Peripheral Nervous System Agents
Healthy
Bronchodilator Agents
Adrenergic Agonists

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Formoterol
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009