Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhalation of HCP0910 and HGP1011 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP0910 and HGP1011 | Drug | 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)) |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period1 |
| |||||||||||||
| Washout1 |
| |||||||||||||
| Period2 |
| |||||||||||||
| Washout2 |
| |||||||||||||
| Period3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 10 subjects for period 1 and 2; 6 subjects for period 3 | Posted | Mean | Standard Deviation | h*pg/mL | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCP0910 and HGP1011 | Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation) HCP0910 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)) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Pharmacology and Therapeutics | Seoul National University Hospital | 82-2-2072-4081 | rheesjin@gmail.com |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Time to Maximum Concentration (Tmax) | Time to maximum concentration of fluticasone | 10 subjects for period 1 and 2; 6 subjects for period 3 | Posted | Median | Full Range | h | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) | Maximum observed concentration of fluticasone | 10 subjects for period 1 and 2; 6 subjects for period 3 | Posted | Mean | Standard Deviation | pg/mL | Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|