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

Asthma Clinical Trial

Official title:

Multiple-dose Pharmacokinetics and Tolerability of "SYN006 HFA MDI" (Budesonide 180ug + Procaterol Hydrochloride 10ug/Dose HFA MDI) Administered Orally to Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165033
• Other study ID #: MCPK10002J1
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2014
• Last updated: June 2, 2015
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2015
• Source: Intech Biopharm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Test drug: SYN006 HFA MDI Batch No: BPP-033-088 Dosage Form: HFA Metered Dose Inhaler Active Substance: Budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose Dosage regimen: Multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen consecutive doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Procaterol 180/10 X 4 puffs
Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Intech Biopharm Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes