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Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. Budesonide and Procaterol therefore have complementary effects, treating two different components of asthma.
Test drug : SYN006 HFA MDI (Budesonide + Procaterol Hydrochloride) Strength: (Budesonide 180ug and Procaterol Hydrochloride 10ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs)
Reference drug 1 : Pulmicort pMDI (Budesonide) Strength: (Budesonide 200ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs)
Reference drug 2 : Meptin Air 10ug (Procaterol Hydrochloride) Strength: (Procaterol Hydrochloride 10ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs)
One dose for each drug (Test, Reference 1 and Reference 2)with an at least 6-day washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYN006 HFA MDI, 180/10 mcg/dose | Experimental | SYN006 HFA MDI(Budesonide/Procaterol Hydrochloride, 180/10mcg), Single dose, 4 puffs |
|
| Pulmicort pMDI | Active Comparator | Budesonide 200mcg, single dose, 4 puffs |
|
| Meptin Air 10mcg | Active Comparator | Procaterol hydrochloride 10mcg, single dose, 4 puffs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug |
| ||
| Procaterol |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | predose, 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose | |
| Maximum plasma concentration (Cmax) | predose, 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose | |
| Time to reach Maximum plasma concentration (Tmax) | predose, 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean residence time (MRT) | To evaluate the safety of the formulations used. The other PK-variables were assessed for description purposes. As safety parameters, adverse events and vital signs (blood pressure, heart rate and body temperature) were recorded. | predose, 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to Period I dosing.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Planned vaccination during the time course of the study.
6. Taking any clinical investigation drug from 2 months prior to Period I dosing.
7. Use of any medication, including herb medicine from 4 weeks before dosing.
8. Donation of 500 mL of blood in the past 3 months prior to dosing or donation of 250 mL of blood in the past 2 months prior to dosing.
9. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
10.A positive test for HIV antibody.
11.In screening subjects will be given training to ensure that subjects are able to correctly use the investigational products. If the subjects, the use of the investigational products lack of proficiency will not be included in this study.
12.Students of National Defense Medical Center.
13.For female subjects, if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C M Perng, M.D | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| Plasma elimination rate constant | To evaluate the safety of the formulations used. The other PK-variables were assessed for description purposes. As safety parameters, adverse events and vital signs (blood pressure, heart rate and body temperature) were recorded. | predose, 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |