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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280358
First Posted: January 23, 2006
Last Update Posted: March 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dey
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Director Clinical Affairs, Dey, LP
ClinicalTrials.gov Identifier: NCT00280358     History of Changes
Other Study ID Numbers: 191-072
First Submitted: January 19, 2006
First Posted: January 23, 2006
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