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

June 2, 2015 updated by: Intech Biopharm Ltd.

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

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

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Neihu
      • Taipei, Neihu, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Budesonide/Procaterol 180/10 X 4 puffs
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
Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose
Other Names:
  • SYN006 HFA MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC) at day 1
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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
Time Frame: predose,0.083,0.167,0.333,0.5,0.75,1,1.5,2,3,4,6,8,10,12 hours post-dose
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 Outcome Measures

Outcome Measure
Time Frame
Accumulation ratio of AUC at day 1 and day 7
Time Frame: 0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose
0.083, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intech Biopharm Ltd.

Investigators

  • Principal Investigator: C W Perng, M.D, Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

February 1, 2013

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

Other Study ID Numbers

  • MCPK10002J1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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