An open label, part-randomised, four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate (FF) when administered as FF inhalation powder from the novel dry powder inhaler in healthy subjects.

An open label, part-randomised, four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate (FF) when administered as FF inhalation powder from the novel dry powder inhaler in healthy subjects. - Four-way crossover, single and repeat dosing BA and BE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37181

Enrollment

Registered

2012-08-06

Start date

2012-09-10

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

chronic inflammation of the bronchial tubes

Interventions

Treatment A A single dose of 300mcg FF on Day 1, followed by 50mcg FF once daily for 7 days, on Days 3-9. Treatment B A single dose of 600 mcg FF on Day 1, followed by 100mcg FF once daily for 7 day

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female Between 18 and 65 years of age inclusive BMI within the range 18.5-29.0 kg/m2 (inclusive).

Exclusion criteria

Exclusion criteria: A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. A positive test for HIV antibody. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma drug concentrations Safety: adverse events, physical examination if medically indicated	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)