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

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00280358
First received: January 19, 2006
Last updated: March 5, 2008
Last verified: March 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

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
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, see Learn About Clinical Studies.

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

Keywords provided by Dey:
Fluticasone
Formoterol
PK Study
Pharmacokinetics

Additional relevant MeSH terms:
Fluticasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014