Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DRUGHCP0910 and HGP1011
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))
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUClast) | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose | Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration (Tmax) | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose | Time to maximum concentration of fluticasone |
| Maximum Observed Concentration (Cmax) | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose | Maximum observed concentration of fluticasone |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inhalation of HCP0910 and HGP1011 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Washout2 | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Inhalation of HCP0910 and HGP1011 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 26.8 years STANDARD_DEVIATION 4.9 |
| Gender Female | 0 Participants |
| Gender Male | 10 Participants |
| Region of Enrollment Korea, Republic of | 10 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Population: 10 subjects for period 1 and 2; 6 subjects for period 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhalation of HCP0910 and HGP1011 | Area Under the Concentration Versus Time Curve (AUClast) | Period 1 | 686.98 h*pg/mL | Standard Deviation 111.36 |
| Inhalation of HCP0910 and HGP1011 | Area Under the Concentration Versus Time Curve (AUClast) | Period 2 | 1247.63 h*pg/mL | Standard Deviation 276.51 |
| Inhalation of HCP0910 and HGP1011 | Area Under the Concentration Versus Time Curve (AUClast) | Period 3 | 1769.58 h*pg/mL | Standard Deviation 370.8 |
Secondary
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
Population: 10 subjects for period 1 and 2; 6 subjects for period 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhalation of HCP0910 and HGP1011 | Maximum Observed Concentration (Cmax) | Period 1 | 95.70 pg/mL | Standard Deviation 20.14 |
| Inhalation of HCP0910 and HGP1011 | Maximum Observed Concentration (Cmax) | Period 2 | 173.56 pg/mL | Standard Deviation 44.32 |
| Inhalation of HCP0910 and HGP1011 | Maximum Observed Concentration (Cmax) | Period 3 | 246.77 pg/mL | Standard Deviation 57.3 |
Secondary
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
Population: 10 subjects for period 1 and 2; 6 subjects for period 3
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Inhalation of HCP0910 and HGP1011 | Time to Maximum Concentration (Tmax) | Period 1 | 0.76 h |
| Inhalation of HCP0910 and HGP1011 | Time to Maximum Concentration (Tmax) | Period 2 | 0.50 h |
| Inhalation of HCP0910 and HGP1011 | Time to Maximum Concentration (Tmax) | Period 3 | 0.88 h |