Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: HCP0910 and HGP1011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 to 45, healthy male subjects (at screening) Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0 Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent Exclusion Criteria: Volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction Subject who already participated in other trials in 3 months Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhalation of HCP0910 and HGP1011<br>Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively. The periods were separated with a washout period of 14 days. | Drug: HCP0910 and HGP1011<br>* 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))<br>* Other names: Fluticasone/Salmeterol and Tiotropium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Concentration (Tmax) | Time to maximum concentration of fluticasone | 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 | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose |