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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Intech Biopharm Ltd.
• Treatments: Budesonide; Procaterol

Criteria

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