Back to resultsBioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.
Primary Purpose
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Budesonide
Procaterol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- 1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- 2. Healthy adults, aged between 20 and 40 years old.
- 3. Subjects with Body Mass Index (BMI) of ≧18.5 and ≦25.0 (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
- 4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- 5. No significant deviation from normal biochemistry examination.
- 6. No significant deviation from normal hematology examination.
- 7. No significant deviation from normal urinalysis examination.
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:
- Lactating women
- Positive pregnancy test (urine) at screening, or prior to dosing
- Do not use adequate contraception during the study
- Women taking oral contraceptives
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
SYN006 HFA MDI, 180/10 mcg/dose
Pulmicort pMDI
Meptin Air 10mcg
Arm Description
SYN006 HFA MDI(Budesonide/Procaterol Hydrochloride, 180/10mcg), Single dose, 4 puffs
Budesonide 200mcg, single dose, 4 puffs
Procaterol hydrochloride 10mcg, single dose, 4 puffs
Outcomes
Primary Outcome Measures
Area Under Curve (AUC)
Maximum plasma concentration (Cmax)
Time to reach Maximum plasma concentration (Tmax)
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02165046
Brief Title
Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.
Official Title
Randomized, Single-dose, Three-way Crossover Study to Assess the Bioavailability of Using SYN006 HFA MDI (Budesonide/Procaterol 180/10mcg) vs Pulmicort pMDI (Budesonide 200 μg) and Meptin Air (Procaterol 10mcg)" in Healthy Volunteer.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intech Biopharm Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYN006 HFA MDI, 180/10 mcg/dose
Arm Type
Experimental
Arm Description
SYN006 HFA MDI(Budesonide/Procaterol Hydrochloride, 180/10mcg), Single dose, 4 puffs
Arm Title
Pulmicort pMDI
Arm Type
Active Comparator
Arm Description
Budesonide 200mcg, single dose, 4 puffs
Arm Title
Meptin Air 10mcg
Arm Type
Active Comparator
Arm Description
Procaterol hydrochloride 10mcg, single dose, 4 puffs
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Type
Drug
Intervention Name(s)
Procaterol
Primary Outcome Measure Information:
Title
Area Under Curve (AUC)
Time Frame
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
Title
Maximum plasma concentration (Cmax)
Time Frame
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
Title
Time to reach Maximum plasma concentration (Tmax)
Time Frame
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
Secondary Outcome Measure Information:
Title
Mean residence time (MRT)
Description
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.
Time Frame
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
Title
Plasma elimination rate constant
Description
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adults, aged between 20 and 40 years old.
3. Subjects with Body Mass Index (BMI) of ≧18.5 and ≦25.0 (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal hematology examination.
7. No significant deviation from normal urinalysis examination.
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:
Lactating women
Positive pregnancy test (urine) at screening, or prior to dosing
Do not use adequate contraception during the study
Women taking oral contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C M Perng, M.D
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.
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