Skip to content

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00280358
Enrollment
30
Registered
2006-01-23
Start date
Unknown
Completion date
2005-12-31
Last updated
2008-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Fluticasone, Formoterol, PK Study, Pharmacokinetics

Brief summary

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

Interventions

DRUGFluticasone Propionate
DRUGFormoterol Fumarate

Sponsors

Dey
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Significant conditions or disease

Design outcomes

Primary

MeasureTime frame
Levels of study medication in blood and urine.

Secondary

MeasureTime frame
Safety/tolerability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026