Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.

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.

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Budesonide; Drug: Procaterol

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Lactating women
  2. Positive pregnancy test (urine) at screening, or prior to dosing
  3. Do not use adequate contraception during the study
  4. Women taking oral contraceptives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYN006 HFA MDI, 180/10 mcg/dose; SYN006 HFA MDI(Budesonide/Procaterol Hydrochloride, 180/10mcg), Single dose, 4 puffs	Drug: Budesonide; Drug: Procaterol
Active Comparator: Pulmicort pMDI; Budesonide 200mcg, single dose, 4 puffs	Drug: Budesonide
Active Comparator: Meptin Air 10mcg; Procaterol hydrochloride 10mcg, single dose, 4 puffs	Drug: Procaterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Intech Biopharm Ltd.
• Investigators: Principal Investigator: C M Perng, M.D, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Budesonide; Procaterol
• Other Study ID Numbers: MCPK09003J1