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

• Sponsor: Dey (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00280358
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Completion Date: Dec 1, 2005

Outcome Measures

Primary Outcome Measures

1. Levels of study medication in blood and urine. []

Secondary Outcome Measures

1. Safety/tolerability []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Significant conditions or disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Dey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00280358
• Other Study ID Numbers: 191-072
• First Posted: Jan 23, 2006
• Last Update Posted: Mar 7, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: Fluticasone; Formoterol; PK Study; Pharmacokinetics
• Additional relevant MeSH terms: Fluticasone; Xhance; Formoterol Fumarate

Study Results

No Results Posted as of Mar 7, 2008