Back to resultsPharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP0910 and HGP1011
Sponsored by
About this trial
This is an interventional screening trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inhalation of HCP0910 and HGP1011
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to Maximum Concentration (Tmax)
Time to maximum concentration of fluticasone
Maximum Observed Concentration (Cmax)
Maximum observed concentration of fluticasone
Full Information
NCT ID
NCT02441114
First Posted
May 6, 2015
Last Updated
November 20, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02441114
Brief Title
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Official Title
A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhalation of HCP0910 and HGP1011
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HCP0910 and HGP1011
Other Intervention Name(s)
Seretide 250 diskus and Spiriva capsule for inhalation, Fluticasone/Salmeterol and Tiotropium
Intervention Description
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))
Primary Outcome Measure Information:
Title
Area Under the Concentration Versus Time Curve (AUClast)
Description
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
Secondary Outcome Measure Information:
Title
Time to Maximum Concentration (Tmax)
Description
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
Title
Maximum Observed Concentration (Cmax)
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
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