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

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ClinicalTrials.gov Identifier: NCT00280358
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
Dey

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Fluticasone Propionate Drug: Formoterol Fumarate Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Levels of study medication in blood and urine.

Secondary Outcome Measures :
  1. Safety/tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant conditions or disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280358


Locations
United States, Kansas
Research Site
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Dey

Responsible Party: Director Clinical Affairs, Dey, LP
ClinicalTrials.gov Identifier: NCT00280358     History of Changes
Other Study ID Numbers: 191-072
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by Dey:
Fluticasone
Formoterol
PK Study
Pharmacokinetics

Additional relevant MeSH terms:
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action