Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler.

Inclusion Criteria

• •Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• •Healthy male or female as determined by a responsible and experienced physician, based on a medical evaluation including \[medical history, physical examination, laboratory tests and cardiac monitoring\]. A subject with a clinical significant abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• •A female subject is eligible to participate if she is of:
• •* Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\]. \[Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\]
• •* Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 10 days after last dose.
• •Body weight ≥ 50 kg and BMI within the range 19.0 - 29.9 kg/m2 (inclusive).
• •Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
• •Response to ipratropium bromide defined as
• •* an increase in sGaw of ≥25% over pre-dose baseline at 2 h following 80μg ipratropium bromide; or
• •* a documented increase in sGaw of ≥25% over pre-dose baseline at 2 h following inhalation of 80 μg of ipratropium bromide within 3 months of screening.
• •AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• •No significant abnormality on 12-lead ECG at screening, including QTcF \< 450msec.
• •Non-smokers (never smoked or not smoking for \>6 months with \<10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
• •Subjects who are able to use the Novel DPI satisfactorily
• •Subjects, who are capable of giving written informed consent, have signed and dated the informed consent form which includes compliance with the requirements and restrictions listed in the consent form.