| Eligibility |
Inclusion Criteria:
1. Healthy male and female volunteers, aged 20-60, inclusive.
2. BMI of 18.0-30.0 kg/m², inclusive. The body weight should be over 50 kg, inclusive.
(BMI will be calculated as weight in kilogram [kg]/height in meters² [m²]).
3. Healthy or non-clinical significant (NCS), according to the medical history, ECG,
chest X-ray and physical examination as determined by the Principal
Investigator/Sub-Investigator.
4. Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure
between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and
temperature between 35.0-37.4?.
5. Screening laboratory values within reference range or NCS as determined by the
Principal Investigator/Sub-Investigator.
6. Ability to comprehend and be informed of the nature of the study, as assessed by
clinical staff. Capable of giving written informed consent prior to receiving any
study medication. Must be able to communicate effectively with clinical staff.
7. Willing to fast for at least 14 hours and to consume standard meals.
8. Availability to volunteer for the entire study duration and willing to adhere to all
protocol requirements.
9. Agree not to have a tattoo, body piercing, or any invasive procedure and blood
donation until the end of the study.
10. Never-smokers; or former smokers who have smoked = 100 cigarettes in their lifetime
and have not consumed any tobacco or tobacco containing products for at least 12
months prior to screening.
11. Subjects who are non-asthmatic, defined as no clinical history of asthma, allergy or
atopy.
12. Able to perform special breathing using nebulizer correctly as per the required
standard.
13. Subjects must fulfill at least one of the following:
- Be surgically sterile for a minimum of 6 months;
- Post-menopausal for a minimum of 1 year;
- Agree to avoid pregnancy and use medically an acceptable method of contraception
from screening day until 30 days after the study ends (last study procedure).
Exclusion Criteria:
1. Known history or presence of any clinically significant hepatic (e.g. active liver
disease, hepatic impairment), renal/genitourinary (e.g. renal impairment),
gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g.
hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis),
neurological, psychiatric, dermatological, hematological disease, or any other medical
conditions, unless determined as not clinically significant by the Principal
Investigator/Sub-Investigator.
2. Presence of any clinically significant illness within 30 days prior to first dosing,
as determined by the Principal Investigator/Sub-Investigator.
3. Presence of any significant physical or organ abnormality as determined by the
Principal Investigator/Sub-Investigator.
4. A positive test result for any of the following: HIV, Hepatitis B surface antigen,
Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine,
opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy
test for female subjects.
5. Known history or presence of:
- Alcohol abuse within one year prior to first drug administration;
- Drug abuse or dependence;
- Hypersensitivity or idiosyncratic reaction to albuterol, its excipients, and/or
related substances;
- Allergy to standardized meal provided by site and/or presence of any dietary
restrictions;
6. Intolerance to and/or difficulty in blood sampling through venipuncture.
7. Abnormal diet patterns (for any reason) during the 4 weeks preceding the study,
including fasting, high protein diets etc.
8. Except for screening procedures, blood donation that results in blood loss of not more
than 250 ml in the past 2 months prior to first dosing; blood loss of more than 250 ml
within 3 months prior to first dosing.
9. Donation of plasma by plasmapheresis within 7 days prior to first drug administration.
10. Individuals who receives an investigational drug from 2 months prior to first drug
administration.
11. Consumption of products containing caffeine/methylxanthines, poppy seeds and/or
alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo
(shown to inhibit cytochrome P450 [CYP] 3A4 activity) within 10 days prior to first
drug administration.
12. Use of any medication, including oral multivitamins, herbal and/or dietary supplements
within 30 days prior to first drug administration (except topical agents without
systemic absorption as determined by the Principal Investigator/Sub-Investigator).
13. Females taking oral or transdermal hormonal contraceptives within 30 days prior to
first drug administration.
14. Females having used implanted, injected, intravaginal, or intrauterine hormonal
contraceptive within 6 months prior to first drug administration.
15. Individuals having undergone any major surgery within 6 months prior to the start of
the study, unless deemed otherwise by Principal Investigator/Sub-Investigator.
16. Using tobacco products, nicotine products (patches, gum etc.) within 6 months prior to
first drug administration.
17. Lactating women.
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