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

NCT02165046 | Completed Phase 1 DMC

• 1 other identifier: MCPK09003J1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Mean residence time (MRT)

  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

  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

Study Arms (3)

SYN006 HFA MDI, 180/10 mcg/dose

EXPERIMENTAL

SYN006 HFA MDI(Budesonide/Procaterol Hydrochloride, 180/10mcg), Single dose, 4 puffs

Drug: Budesonide; Drug: Procaterol

Pulmicort pMDI

ACTIVE COMPARATOR

Budesonide 200mcg, single dose, 4 puffs

Drug: Budesonide

Meptin Air 10mcg

ACTIVE COMPARATOR

Procaterol hydrochloride 10mcg, single dose, 4 puffs

Drug: Procaterol

Interventions

Budesonide DRUG

Pulmicort pMDI; SYN006 HFA MDI, 180/10 mcg/dose

Procaterol DRUG

Meptin Air 10mcg; SYN006 HFA MDI, 180/10 mcg/dose

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Healthy adults, aged between 20 and 40 years old.
• \. Subjects with Body Mass Index (BMI) of ≧18.5 and ≦25.0 (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
• \. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
• \. No significant deviation from normal biochemistry examination.
• \. No significant deviation from normal hematology examination.
• \. No significant deviation from normal urinalysis examination.

You may not qualify if:

• \. History of drug or alcohol abuse within the past year.
• \. Medical history of severe drug allergy or sensitivity to analogous drug.
• \. Evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to Period I dosing.
• \. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
• \. Planned vaccination during the time course of the study.
• \. Taking any clinical investigation drug from 2 months prior to Period I dosing.
• \. Use of any medication, including herb medicine from 4 weeks before dosing.
• \. 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.
• \. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
• A positive test for HIV antibody.
• 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.
• Students of National Defense Medical Center.
• For female subjects, if they meet any of the following criteria:
• Lactating women
• Positive pregnancy test (urine) at screening, or prior to dosing

Sponsors & Collaborators

• Intech Biopharm Ltd.: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Procaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• C M Perng, M.D

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 17, 2014
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

TW (1)