Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers

NCT02165033 | Completed Phase 1 DMC

• 1 other identifier: MCPK10002J1
• Study Type: interventional
• Target: 16
• 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

Outcome Measures

Primary Outcomes (6)

• Area Under Curve (AUC) at day 1

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

• Peak Plasma Concentration (Cmax) at day 1

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

• Tmax at day 1

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

• Area Under Curve (AUC) at day 7

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

• Peak Plasma Concentration (Cmax) at day 7

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

• Tmax at day 7

  predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose

Secondary Outcomes (1)

• Accumulation ratio of AUC at day 1 and day 7

  0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose

Study Arms (1)

Budesonide/Procaterol 180/10 X 4 puffs

EXPERIMENTAL

Multiple dose of SYN006 HFA MDI (Budesonide 180ug + Procaterol 10ug/puff), 4 puffs each day for consecutive 7 days

Drug: Budesonide/Procaterol 180/10 X 4 puffs

Interventions

Budesonide/Procaterol 180/10 X 4 puffs DRUG

Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose

Also known as: SYN006 HFA MDI

Budesonide/Procaterol 180/10 X 4 puffs

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.
• Clinical laboratory test: within limit of normal range or acceptable to investigator.

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. Creatinine \> 2UNL (upper normal limit); Liver enzymes \> 2UNL; Total bilirubin \> 2UNL.
• 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 500mL of blood in the past 3 months prior to dosing or donation of 250mL 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, Neihu, 114, Taiwan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• C W Perng, M.D

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 17, 2014
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

TW (1)