This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
10
Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
Seoul National University Hospital
Seoul, South Korea
Area Under the Concentration Versus Time Curve (AUClast)
Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration
Time frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Time to Maximum Concentration (Tmax)
Time to maximum concentration of fluticasone
Time frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Maximum Observed Concentration (Cmax)
Maximum observed concentration of fluticasone
Time frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
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