Approval Probability
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Also known as Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend)
Salbutamol Sulphate UD-DPI Blister · 1 trial · 1 indication
PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 12 hours (hr) (AUC \[0-12hr\]) and/ or area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-infinity\]) and/ or area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC \[0-t\]) and maximum observed concentration (Cmax).
PK parameters include: AUC(0- infinity) or AUC(0-t) and Cmax
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Subjects will receive following six treatments each in six period, with a 3-days minimum wash-out period, between each treatment period: 1) Single dose (SD) salbutamol (200mcg per blister from 1.6% blend) delivered via the UD-DPI by inhalation of 3 Blisters (BTR) giving a total dose of 600mcg; 2) SD salbutamol sulphate (200mcg per BTR from a 1.0% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 600mcg; 3) SD salbutamol (150mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 450mcg; 4) SD salbutamol (250mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 750mcg; 5) SD of salbutamol (200mcg per BTR) delivered via the Diskus by inhalation of 3 BTR giving a total dose of 600mcg; 6) SD salbutamol (100mcg per actuation) delivered via the MDI giving a total dose of 600mcg |
| Part B | EXPERIMENTAL | Prior to the start of Part B, a decision will be made regarding the UD-DPI products to be used in Part B. Subjects will receive following 6 treatments each in 6 period, with a 3-days minimum wash-out period, between each treatment period: 1) SD salbutamol (selected from Part A) delivered via the UD-DPI without activated charcoal (AC) by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 2) SD salbutamol (selected from Part A) delivered via the UD-DPI with AC by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 3) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus without AC (total dose 600mcg); 4) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus with AC (total dose 600mcg); 5) SD salbutamol 6 inhalations (100mcg) delivered via the MDI without AC (total dose 600mcg); 6) SD salbutamol 6 inhalations (100mcg) delivered via the MDI with AC (total dose 600mcg) |
| Name | Type | Description |
|---|---|---|
| Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 150mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend) | DRUG | Salbutamol Sulphate 250mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend) | DRUG | Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol Diskus 200mcg Blister | DRUG | Salbutamol Diskus 200mcg will be supplied as blister strip contained within the Diskus device. Each blister contains a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients |
| Salbutamol MDI 100mcg | DRUG | Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device |
| Salbutamol Sulphate UD-DPI Blister (selected from Part A) | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A) | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Diskus 200mcg Blister without activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol Diskus 200mcg Blister with activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol MDI 100mcg without activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
| Salbutamol MDI 100mcg with activated charcoal | DRUG | Formulation will be determined depending on the outcome of Part A. |
Inclusion Criteria * Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>=50 kg and body mass index within the range 19.0 - 34.0 kilogram per square meter (inclusive). * A female subject is eligible to participate if she is of: No...